Devices and methods for minimally invasive kidney stone removal by combined aspiration and irrigation

ABSTRACT

Disclosed herein are systems, devices, and methods for the removal of objects from the body. The device may be a urethral catheter configured to aspirate kidney stones from the urinary tract through one or more aspiration ports at the distal face or along a lateral side of the catheter. The catheter may include one or more irrigation ports at the distal face or along the lateral side of the catheter for dislodging kidney stones. The device may be steerable. The spatial arrangement of the one or more irrigation ports with respect to the one or more aspiration ports may vary. The device may include an irrigation tube and/or a shield member configured to spatially confine the kidney stones adjacent the catheter. Various temporal patterns of aspiration and irrigation are disclosed for optimizing removal of kidney stones.

CROSS-REFERENCE

The present application is a continuation of U.S. patent applicationSer. No. 16/966,856 filed on Jul. 31, 2020, as the 35 USC 371 NationalStage filing of PCT/US2019/016172 filed on Jan. 31, 2019, which claimsthe benefit of and priority to U.S. Provisional Patent Application No.62/649,430 filed on Mar. 28, 2018, and further to U.S. ProvisionalPatent Application No. 62/625,766 filed on Feb. 2, 2018, all of theseapplications are incorporated herein by reference in their entirety.

BACKGROUND

The present invention relates to systems and methods for the guidedremoval of objects in vivo. In particular, the invention is directed toa removal device adapted to traverse compact areas utilizing anavigation mechanism, and more specifically, to capture and/or removedebris through a vacuum tube that is in communication with a suctionsource.

Kidney stones are a common medical problem that negatively impactmillions of individuals worldwide. Kidney stones include one or moresolid masses of material that are usually made of crystals and form inparts of the urinary tract including in the ureter, the kidney, and/orthe bladder of the individual. Kidney stones range in size from smaller(less than about 1 cm) to very large (more than 4 cm) and may causesignificant pain to the individual and damage to the kidney. Theoverwhelming majority of stones that are treated by surgeons are lessthan 1 cm.

The recommended treatment for removal of the kidney stones variesaccording to numerous factors including the size of the kidney stones,the number of kidney stones, and the location of the kidney stones. Themost common treatments for kidney stones are shock wave lithotripsy(ultrasound waves used to fracture the stones), ureteroscopy (fractureand removal of the stones using an endoscope that is introduced throughthe bladder), and percutaneous nephrolithotomy (fracture and removal ofthe stones using an endoscope that is introduced through a sheath placedthrough the patient's back into the kidney).

The largest kidney stones are usually removed through percutaneousnephrolithotomy or nephrolithotripsy, or through other similarprocedures. In these procedures, a small incision is made through thepatient's back adjacent the kidney and a sheath is passed into thekidney to accommodate a larger endoscope used to fracture and removestones. The stone may be removed directly through the tube or may bebroken up into small fragments while still in the patient's body andthen removed via a vacuum or other known methods (nephrolithotripsy).

There are numerous drawbacks associated with nephrolithotomy,nephrolithotripsy, and other invasive surgeries requiring an incision inthe skin. Namely, such surgical techniques may require significantlymore anesthesia administered to the patient, the surgeries are morecomplicated and pose a higher risk of infection and complications forthe patient, and the surgeries require a substantial incision in thepatient, which may leave a scar. Additionally, given the invasiveness ofthe procedure, percutaneous procedures are usually not preferred forsmaller kidney stones (e.g., less than 1 cm) depending on the size andlocation of the stones.

In contrast, traditionally, smaller kidney stones have been treatedusing other, less invasive techniques including through ureteroscopy. Inureteroscopy, the surgeon typically inserts a ureteroscope into theurethra through the bladder and the ureter to provide the surgeon with adirect visualization of the kidney stone(s) which may reside in theureter or kidney. The surgeon then removes the kidney stone directlyusing a basketing device if the kidney stone is small enough to passthrough the urinary tract without difficulty, or the surgeon fracturesthe kidney stone into smaller pieces using a laser or other breakingdevice. After breaking the kidney stone into smaller pieces, the surgeonremoves the laser or breaking device and inserts a basket or otherobject to capture the kidney stone fragments under the directvisualization of the ureteroscope. Upon retrieving some of the kidneystone fragments, the surgeon removes the basket from the patient andempties the kidney stone fragments therefrom. This process is repeateduntil clinically significant kidney stones and kidney stone fragmentsare broken up and removed from the body.

It should be apparent that this process is extremely time consuming,costly, and inefficient because the surgeon is required to insert andremove the scope and basket into and out of the patient many times tocompletely remove the kidney stones and kidney stone fragmentstherefrom. Using a basket removal device to capture kidney stones orkidney stone fragments suffers from other drawbacks in that the basketis difficult to position adjacent the kidney stone fragments andmaneuver in a manner that effectively retrieves the fragments. Thetraining required for such a procedure is not insignificant and theaforementioned basket removal technique is difficult for even the mostskilled surgeons. Additionally, the surgeon is susceptible to handfatigue due to the extended amount of time required to operate thekidney stone retrieval baskets. Further, the patient is required to beunder local anesthesia and/or remain immobile over an extended amount oftime. Still further, the basket retrieval devices cause irritation tothe urinary tract due to the repeated insertion and removal therefrom.Thus, there is an unmet need for new devices and methods that permitminimally invasive removal of kidney stones.

SUMMARY

Disclosed herein is a method of removing a kidney stone from a kidney ofa patient. The method comprises inserting a catheter into the urethra ofthe patient and advancing the catheter to a location within the kidneyproximate to the kidney stone. The catheter has a distal portionsteerable in one or more directions. The distal portion includes anaspiration port for providing suction and an irrigation port forproviding irrigation fluid. The method further comprises steering thedistal steerable portion so that the steerable portion is bent into aconfiguration in which the kidney stone is aligned with the aspirationport, providing irrigation through the irrigation port, and providingsuction through the catheter to aspirate the kidney stone from thekidney without removing the catheter from the kidney.

In some implementations, suction and irrigation may not be providedduring the steering of the distal steerable portion. The catheter may berotated during the steering. Suction and irrigation may be halted afterthe kidney stone is aspirated. After the kidney stone is aspirated, thedistal steerable portion can be bent into a configuration in which asecond kidney stone is aligned with the aspiration port. Irrigation maybe provided continuously and suction provided intermittently during aperiod. Suction may be provided continuously and irrigation providedintermittently during a period. Suction and irrigation may both beprovided continuously during a period. Suction and irrigation may bothbe provided intermittently during a period. When providedintermittently, suction and irrigation may be provided simultaneously.When provided intermittently, suction may be applied continuously duringany interval in which irrigation is not applied, and irrigation may beapplied continuously during any interval in which suction is notprovided.

The catheter may have a handle configured to be positioned outside thebody of the patient. The handle may have a control for a user to stopand/or start the suctioning. The handle may have a control for a user tostop and/or start the irrigation. The handle may have a control for auser to stop and/or start the suction and the irrigation. The controlcan be a hole configured to be covered by a single finger of the user.Covering the hole may cause suction to be provided.

The method may comprise adjusting the curvature of the distal steerableportion. Adjusting the curvature of the distal steerable portion maycomprise pulling and/or pushing a lever on a handle of the catheterpositioned outside of the body. The lever may be coupled to the distalsteerable portion by one or more pull wires. The method may comprisepositioning the distal steerable portion in a calyx of the kidney afteradjusting the curvature of the distal steerable portion. The method maycomprise rotating the catheter after applying a curvature to the distalsteerable portion of the catheter during suctioning. The method maycomprise adjusting the curvature of the steerable distal portion tosweep laterally in a side-to-side motion during suctioning. The methodmay comprise retracting the catheter in a proximal direction within thekidney during suctioning. The method may comprise advancing the catheterin a distal direction within the kidney during suctioning. The methodmay comprise reciprocating the catheter in a distal and proximaldirection within the kidney during suctioning.

The catheter may have a lateral aspiration port positioned on a firstside of the catheter and an irrigation port positioned on a distal faceof the catheter. The method may comprise bending the distal end of thecatheter in the direction of the lateral aspiration port such thatirrigation fluid is directed toward the lateral aspiration port duringsuction. Providing irrigation may comprise directing an irrigation fluidfrom a distal end of the catheter in a direction substantially parallelto a distal facing direction of the catheter. Providing irrigation maycomprise directing an irrigation fluid from a distal end of the catheterin a direction substantially away from an axis of a distal-facingaspiration port. Providing irrigation may comprise directing anirrigation fluid from a distal end of the catheter in a directionsubstantially toward an axis of a distal-facing aspiration port.Providing irrigation may comprise directing irrigation fluid in aradially outward direction from a distal end of the catheter. Providingirrigation may comprise directing irrigation fluid in a radially inwarddirection from a distal end of the catheter. Providing irrigation maycomprise directing irrigation fluid from an irrigation port on a distalface of the catheter and from a lateral irrigation port on a side of thecatheter.

Providing suction may comprise aspirating through a lateral-facingaspiration port on a side of the catheter and providing irrigation maycomprise directing irrigation fluid from a lateral-facing irrigationport. The lateral-facing aspiration port may be positioned distally ofthe lateral-facing irrigation port or proximally of the lateral-facingirrigation port. The lateral-facing irrigation port may directirrigation fluid in an axial direction toward the lateral-facingaspiration port. Providing irrigation may comprise steering a distalface of the catheter to curve in a direction toward an aspiration port.The distal face may have an irrigation port.

The method may comprise inserting an ancillary device laterally adjacentthe catheter. The ancillary device may be a guidewire. The method mayfurther comprise axially translating the ancillary device with respectto the catheter. The ancillary device may have a steerable distalportion and the method may further comprise steering the distal portion.The ancillary device may be an irrigation tube and the method mayfurther comprise providing irrigation from the ancillary device. Themethod may comprise positioning the irrigation tube to direct irrigationfluid toward a lateral-facing aspiration port on a side of the catheter.The method may comprise guiding kidney stones toward an aspiration porton the catheter using a shield on the ancillary device. The shield mayhave a collapsed configuration and an expanded configuration and themethod may comprise expanding the shield after insertion of theancillary device into the bladder or kidney.

Steering the distal steerable portion may comprise bending the distalsteerable portion in more than one direction. Providing irrigation maycomprise providing an irrigation stream selected from the groupconsisting of: a flat stream, a fanned stream, and a conical stream. Thecatheter may have a plurality of irrigation ports, and providingirrigation may comprise producing a single jet stream of irrigation fromthe plurality of irrigation ports or producing a shower effect ofirrigation streams. Providing irrigation may comprise producing anirrigation stream having a vortex effect.

The location within the kidney may be a first pole of the kidney. Themethod may comprise steering the distal steerable portion to sweep thefirst pole of the kidney, then repositioning the catheter in a secondpole of the kidney and steering the distal steerable portion to sweepthe second pole of the kidney, and then repositioning the catheter in athird pole of the kidney and steering the distal steerable portion tosweep the third pole of the kidney. The first pole may be the upper poleof the kidney, the second pole may be the middle pole of the kidney, andthe third pole may be the lower pole of the kidney. The sweep maycomprise incremental movements and suctioning and/or irrigation may beperformed only while the catheter is stationary between incrementalmovements, during incremental movements, or a combination of both.Providing irrigation may comprise flushing the upper pole and the middlepole of the kidney with irrigation fluid. Flushing may fill, or at leastpartially fill the calyx, which may advantageously prevent suctioning ofkidney tissue as described elsewhere herein. Flushing may be used toattempt to move any kidney stones to another pole, such as from theupper and middle poles into the lower pole, in some embodiments.Providing suction may comprise aspirating kidney stones from the lowerpole of the kidney.

The method may comprise providing a non-suctioning period of time duringwhich no suction is provided through the aspiration port. During thenon-suctioning period, the aspiration port may be in fluid communicationwith the ambient atmosphere outside of the patient, therebyequilibrating the pressure between the inside of the kidney and theambient atmosphere.

Providing irrigation may comprise providing a pulsatile flow ofirrigation fluid. The pulsatile flow may be provided at a frequency ofat least about 1 Hz. The pulsatile flow may comprise stopping andstarting irrigation. The pulsatile flow may comprise increasing anddecreasing the irrigation pressure while maintaining a delivery ofirrigation fluid. Providing suction may comprise providing pulsatilesuctioning. Pulsatile suctioning may be provided at a frequency of atleast about 1 Hz. The pulsatile suctioning may comprise stopping andstarting suctioning. The pulsatile suctioning may comprise increasingand decreasing the suction pressure while maintaining at least somesuctioning. Providing irrigation and providing suction may compriseproviding synchronized pulsatile irrigation and pulsatile suctioning.Irrigation pressure may be increased as suction pressure is decreasedand irrigation pressure may be decreased as suction pressure isincreased. Irrigation pressure may be increased as suction pressure isincreased and irrigation pressure may be decreased as suction pressureis decreased. Providing irrigation and providing suction may comprisesuspending the kidney stone in the irrigation fluid. Providingirrigation and providing suction may comprise fluidizing the kidneystone with the irrigation fluid.

In a further aspect of the invention, disclosed herein is a method ofremoving a kidney stone from a kidney of a patient. The method comprisesinserting a catheter into the urethra of the patient and advancing thecatheter to a location within the kidney proximate to the kidney stone.The catheter has a distal portion steerable in one or more directions.The distal portion has an aspiration port for providing suction and anirrigation port for providing irrigation fluid. The method furthercomprises guiding the kidney stone from a first location in the kidneyto a second location in the kidney and positioning the aspiration portproximate to the kidney stone. The method further comprises providingirrigation through the irrigation port and providing suction through thecatheter to aspirate the kidney stone from the kidney without removal ofthe catheter from the kidney.

In some implementations, suction and irrigation may not be provided fromthe catheter during the guiding of the kidney stone. Guiding the kidneystone from the first location to the second location may comprise movingthe kidney stone using an ancillary device. The kidney stone may beguided using a shield or basket device. The kidney stone may be guidedusing irrigation provided by an ancillary irrigation tube. The kidneystone may be guided using the distal portion of the catheter. The kidneystone may be guided using irrigation provided by the irrigation port.Suction and irrigation may be halted after the kidney stone isaspirated. After the kidney stone is aspirated, a second kidney stonemay be guided from a third location in the kidney to the first locationin the kidney or a fourth location in the kidney.

Irrigation may be provided continuously and suction providedintermittently during a period. Suction may be provided continuously andirrigation provided intermittently during a period. Suction andirrigation may be provided continuously during a period. Suction andirrigation may both be provided intermittently during a period. Whenprovided intermittently, suction and irrigation may be providedsimultaneously. When provided intermittently, suction may be appliedcontinuously during any interval in which irrigation is not applied, andirrigation may be applied continuously during any interval in whichsuction is not provided.

The catheter may have a handle configured to be positioned outside thebody of the patient. The handle may have a control for a user to stopand/or start the suctioning. The handle may have a control for a user tostop and/or start the irrigation. The handle may have a control for auser to stop and/or start the suction and the irrigation. The controlmay be a hole configured to be covered by a single finger of the user.Covering the hole may cause the suction to be provided.

The catheter may have a distal steerable portion and the method maycomprise adjusting the curvature of the distal steerable portion in oneor more directions. Adjusting the curvature of the distal steerableportion may comprise pulling, turning, and/or pushing a lever on ahandle of the catheter positioned outside of the body. The lever may becoupled to the distal steerable portion by one or more pull wires. Themethod may comprise positioning the distal steerable portion in a calyxof the kidney after adjusting the curvature of the distal steerableportion. The method may comprise rotating the catheter after applying acurvature to the distal steerable portion of the catheter duringsuctioning. The method may comprise adjusting the curvature of thedistal steerable portion to sweep laterally in a side-to-side motionduring suctioning. The method may comprise retracting the catheter in aproximal direction within the kidney during suctioning. The method maycomprise advancing the catheter in a distal direction within the kidneyduring suctioning. The method may comprise reciprocating the catheter ina distal and proximal direction within the kidney during suctioning.

The catheter may have a lateral aspiration port positioned on a firstside of the catheter and an irrigation port positioned on a distal faceof the catheter. The method may comprise bending the distal end of thecatheter in the direction of the lateral aspiration port such thatirrigation fluid is directed toward the lateral aspiration port duringsuction. Providing irrigation may comprise directing an irrigation fluidfrom a distal end of the catheter in a direction substantially parallelto a distal facing direction of the catheter. Providing irrigation maycomprise directing an irrigation fluid from a distal end of the catheterin a direction substantially away from an axis of a distal-facingaspiration port. Providing irrigation may comprise directing anirrigation fluid from a distal end of the catheter in a directionsubstantially toward an axis of a distal-facing aspiration port.Providing irrigation may comprise directing irrigation fluid in aradially outward direction from a distal end of the catheter. Providingirrigation may comprise directing irrigation fluid in a radially inwarddirection from a distal end of the catheter. Providing irrigation maycomprise directing irrigation fluid from an irrigation port on a distalface of the catheter and from a lateral irrigation port on a side of thecatheter.

Providing suction may comprise aspirating through a lateral-facingaspiration port on a side of the catheter and providing irrigation maycomprise directing irrigation fluid from a lateral-facing irrigationport. The lateral-facing aspiration port may be positioned distally ofthe lateral-facing irrigation port or proximally of the lateral-facingirrigation port. The lateral-facing irrigation port may directirrigation fluid in an axial direction toward the lateral-facingaspiration port. Providing irrigation may comprise steering a distalface of the catheter to curve in a direction toward an aspiration port.The distal face may have an irrigation port.

The method may comprise inserting an ancillary device laterally adjacentthe catheter. The ancillary device may be a guidewire. The method maycomprise axially translating the ancillary device with respect to thecatheter. The ancillary device may have a steerable distal portion, andthe method may comprise steering the distal portion. The ancillarydevice may be an irrigation tube, and the method may comprise providingirrigation from the ancillary device. The method may comprisepositioning the irrigation tube to direct irrigation fluid toward alateral-facing aspiration port on a side of the catheter. The method maycomprise guiding kidney stones toward an aspiration port on the catheterusing a shield on the ancillary device. The shield may have a collapsedconfiguration and an expanded configuration, and the method may compriseexpanding the shield after insertion of the ancillary device into thebladder or kidney.

Steering the distal steerable portion may comprise bending the distalsteerable portion in more than one direction. Providing irrigation maycomprise providing an irrigation stream selected from the groupconsisting of: a flat stream, a fanned stream, and a conical stream. Thecatheter may have a plurality of irrigation ports, and providingirrigation may comprise producing a single jet stream of irrigation fromthe plurality of irrigation ports or producing a shower effect ofirrigation streams. Providing irrigation may comprise producing anirrigation stream having a vortex effect.

The first location within the kidney may be a first pole of the kidney.The method may comprise steering the distal steerable portion to sweepthe first pole of the kidney, then repositioning the catheter in asecond pole of the kidney and steering the distal steerable portion tosweep the second pole of the kidney, and then repositioning the catheterin a third pole of the kidney and steering the distal steerable portionto sweep the third pole of the kidney. The first pole may be the upperpole of the kidney, the second pole may be the middle pole of thekidney, and the third pole may be the lower pole of the kidney. Thesweep may comprise incremental movements and suctioning and irrigationmay be performed only while the catheter is stationary betweenincremental movements. Providing irrigation may comprise flushing theupper pole and the middle pole of the kidney with irrigation fluid tomove kidney stones from the upper and middle poles into the lower pole,and providing suction may comprise aspirating kidney stones from thelower pole of the kidney.

The method may comprise providing a non-suctioning period of time duringwhich no suction is provided through the aspiration port. During thenon-suctioning period, the aspiration port may be in fluid communicationwith the ambient atmosphere outside of the patient, therebyequilibrating the pressure between the inside of the kidney and theambient atmosphere.

Providing irrigation may comprise providing a pulsatile flow ofirrigation fluid. The pulsatile flow may be provided at a frequency ofat least about 1 Hz. The pulsatile flow may comprise stopping andstarting irrigation. The pulsatile flow may comprise increasing anddecreasing the irrigation pressure while maintaining a delivery ofirrigation fluid. Providing suction may comprise providing pulsatilesuctioning. Pulsatile suctioning may be provided at a frequency of atleast about 1 Hz. The pulsatile suctioning may comprise stopping andstarting suctioning. The pulsatile suctioning may comprise increasingand decreasing the suction pressure while maintaining at least somesuctioning. Providing irrigation and providing suction may compriseproviding synchronized pulsatile irrigation and pulsatile suctioning.Irrigation pressure may be increased as suction pressure is decreasedand irrigation pressure may be decreased as suction pressure isincreased. Irrigation pressure may be increased as suction pressure isincreased and irrigation pressure may be decreased as suction pressureis decreased. Providing irrigation and providing suction may comprisesuspending the kidney stone in the irrigation fluid. Providingirrigation and providing suction may comprise fluidizing the kidneystone with the irrigation fluid.

In a further aspect of the invention, disclosed herein is a removaldevice for removal of kidney stones from a patient. The removal deviceincludes a catheter having a distal steerable portion steerable in oneor more directions. The distal portion includes an aspiration port andan irrigation port. The catheter further includes a vacuum lumen influid communication with the aspiration port for providing suction tothe aspiration port and an irrigation lumen in fluid communication withthe irrigation port for providing irrigation to the irrigation port.

The aspiration port and the irrigation port may be distal facing. Thedistal-facing irrigation port may be configured to direct the irrigationfluid in a direction substantially parallel to the distal facingdirection. The distal-facing irrigation port may be configured to directthe irrigation fluid in a direction away from the distal-facingaspiration port. The distal-facing irrigation port may be configured todirect the irrigation fluid in a direction substantially toward thedistal-facing aspiration port. The distal-facing irrigation port may beconfigured to direct irrigation fluid in a radially outward direction.The distal-facing irrigation port may be configured to direct irrigationfluid in a radially inward direction.

The irrigation port may be distal facing and the aspiration port may belateral facing. The distal-facing irrigation port may be positioned on aside of the catheter substantially opposite the lateral aspiration port.

The aspiration port may be lateral facing and the irrigation port may belateral facing. The lateral-facing aspiration port may be positioneddistally of the lateral-facing irrigation port or proximally of thelateral-facing irrigation port. The lateral-facing aspiration port maybe configured to direct irrigation fluid in an axial direction towardthe lateral-facing aspiration port.

The catheter may haves an irrigation tube in fluid communication withthe irrigation lumen extending through and distally beyond adistal-facing aspiration port of the vacuum tube. The irrigation tubemay have a lateral-facing irrigation port on a side of the irrigationtube closest to a center of the distal-facing aspiration port. A distalface of the irrigation tube may be configured to curve in a directiontoward a center of the distal-facing aspiration port.

The aspiration port may be lateral facing and the irrigation port may bedistal facing. The distal portion of the catheter may be curved orconfigured to be bent along a side of the catheter such that irrigationfluid from the irrigation port is directed at least partially in aproximal direction toward the lateral-facing aspiration port.

The distal steerable portion of the catheter may have a first steerableportion configured to bend in a first direction and a second steerableportion configured to bend in a second direction. The first steerableportion may be positioned at least partially distally of the secondsteerable portion. The first direction and the second direction may bethe same or may be different. The first direction and the seconddirection may lie in the same plane or in different planes. Theaspiration port may be within the first steerable portion, within thesecond steerable portion, or within a transition between the firststeerable portion and the second steerable portion.

The removal device may include an ancillary device configured to bepositioned laterally adjacent the catheter. The ancillary device may bea guidewire. The ancillary device may be axially translatable withrespect to the catheter. The ancillary device may have a steerabledistal portion. The ancillary device may be an irrigation tube. Theirrigation tube may be configured to direct irrigation fluid toward alateral-facing aspiration port on a side of the catheter. The removaldevice may have a shield configured to guide kidney stones toward anaspiration port on the catheter. The shield may have a mesh allowingfluid flow therethrough. The mesh may be sized to prevent passage ofkidney stones through the shield. The shield may have a distal facepositioned near or at a proximal edge of a lateral-facing aspirationport on the catheter. The shield may have a proximal face positionednear or at a distal edge of a lateral-facing aspiration port on thecatheter. The shield may increase in width as it extends radiallyoutward away from the catheter. The shield may be configured to wrap atleast partially around a circumference of the catheter. The shield mayhave a collapsed configuration configured for insertion into the urethraand an expanded configuration configured for use within the bladder orkidney.

The removal device may have a handle attached to the proximal end of thecatheter. The handle may have a port configured to prevent the deliveryof suction pressure to a distal end of the catheter when the port isoccluded and to allow the delivery of suction pressure to a distal endof the catheter when the port is unoccluded. The port may be furtherconfigured to prevent the delivery of irrigation fluid to a distal endof the catheter when the port is occluded and to allow the delivery ofirrigation fluid to a distal end of the catheter when the port isunoccluded. Alternatively, the port may be further configured to preventthe delivery of irrigation fluid to a distal end of the catheter whenthe port is unoccluded and to allow the delivery of irrigation fluid toa distal end of the catheter when the port is occluded. The port mayprovide an open fluid communication between the distal end of thecatheter and the ambient atmosphere outside of the body.

The removal device may have a lever configured to be pivoted in a firstdirection around a pivot point. The lever may be attached to a firstpull wire, wherein pivoting the lever in the first direction retractsthe first pull wire to cause a steerable portion of the catheter to bendtoward a first side of the catheter along which the first pull wireextends. The lever may be attached to a second pull wire on an oppositeside of the pivot point as the first pull wire, wherein pivoting thelever in a second direction, opposite the first direction, retracts thesecond pull wire to cause a steerable portion of the catheter to bendtoward a second side of the catheter along which the second pull wireextends. The second side may be substantially opposite the first side.

The catheter may be configured to create an irrigation stream selectedfrom the group consisting of: a flat stream, a fanned stream, and aconical stream. The catheter may have a plurality of irrigation ports.The irrigation ports may be configured to produce a single jetirrigation stream or to produce a shower effect of irrigation streams.The catheter may be configured to produce a vortex in an irrigationstream. The catheter may be configured to provide pulsatile irrigation.The catheter may be configured to provide pulsatile suctioning.

In a further aspect of the invention, disclosed herein is a method ofremoving a kidney stone from a kidney of a patient. The method comprisesinserting a catheter into the urethra of the patient and advancing thecatheter to a location within the kidney proximate to the kidney stone.The catheter has a distal portion having an aspiration port forproviding suction and an irrigation port for providing irrigation fluid.The method further comprises moving the kidney stone such that it isaligned with the aspiration port, providing suction through the catheterto aspirate the kidney stone from the kidney without removal of thecatheter from the kidney, and providing irrigation through theirrigation port.

Moving the kidney stone may comprise moving the kidney stone with theirrigation, moving the kidney stone using an ancillary device, and/ormoving the kidney stone by contacting it with the catheter. The methodmay comprise contacting the kidney stone with the distal portion of thecatheter. The distal portion of the catheter may be steerable.

In a further aspect of the invention, disclosed herein is a catheter forremoval of kidney stones. The catheter has a tube portion, a handleportion coupled to the tube portion, and a plurality of pull wires. Thetube portion has a vacuum lumen and an irrigation lumen. The vacuumlumen may have an inner diameter greater than 2 mm. The tube portion hasa distal section and a proximal section. The distal section may have alength between 1 inch and 5 inches and a durometer of less than 40 D,and the proximal section may have a length greater than 15 inches and adurometer of greater than 50 D. The handle portion has a vacuum lumenhaving first and second openings and an irrigation lumen having firstand second openings. The handle portion vacuum lumen first opening is influid communication with the tube portion vacuum lumen and the handleportion irrigation lumen first opening is in fluid communication withthe tube portion irrigation lumen. The vacuum lumen second opening isconfigured to connect to a vacuum source and the irrigation lumen secondopening is configured to connect to an irrigation source. The handleportion has an additional opening into the handle portion vacuum lumensuch that the handle portion vacuum lumen is in fluid communication withambient air outside of the handle through the side opening. Theplurality of pull wires run from the tube portion distal section to oneor more wire pull members on the handle portion. Pulling on one or morethe pull wires using the wire pull members causes the tube portiondistal section to bend in one or more directions.

In some embodiments, the vacuum lumen may have a diameter greater than2.5 mm, a diameter between 2.5 mm and 3 mm, and/or a diameter of about2.7 mm. The tube portion distal section may have a length from 1.5 to3.5 inches, and/or a length from 2 to 3 inches. The tube portion distalsection may have a durometer between about 30 D to 39 D and/or adurometer of about 35 D. In some embodiments, the tube portion distalsection may have a durometer between about 30D and 55D. In someembodiments, the durometer may be less than 30D. The tube portionproximal section may have a length of 20 inches to 30 inches. The tubeportion proximal section may have a durometer of 55 D to 70 D, adurometer of 60 D to 65 D, and/or a durometer of about 63 D. The tubeportion may have a middle section between the proximal and distalsections. The middle section may have a length between 2 inches and 5inches and a durometer between 40 D and 60 D. The tube portion middlesection may have a length from 3 inches to 4 inches. The tube portionmiddle section may have a durometer between 50 D and 60 D and/or adurometer of about 55 D.

The tube portion vacuum lumen may be formed by an inner tube and thetube portion irrigation lumen may be formed by an outer tube surroundingthe inner tube. The inner tube may have an outer liner, an inner liner,and a wire braid. In some embodiments, the outer liner may comprisePEBAX®, nylon, and/or other plastics. In some embodiments, higherdurometer regions (e.g., more proximal regions) may comprise nylon andlower durometer regions (e.g., more distal regions) may comprise PEBAX®.The inner liner may comprise PEBAX®, PTFE, polypropylene, polyurethane,nylon, and/or other plastics. The wire braid may be encapsulated withinthe outer and inner liners. The catheter may comprise a plurality oftubes through which the pull wires extend. The tubes may comprise PTFE.The catheter may comprise a plurality of tubes extending through thewire braid, wherein the pull wires extend through the tubes. The sideopening may be coverable by a human finger. The one or more wire pullmembers may each include a lever pivotably coupled to the handleportion. The one or more wire pull members may include two wire pullmembers having a first lever and a second lever. The first lever andsecond lever may be positioned on substantially opposite sides of thehandle portion. The plurality of pull wires may include a first pullwire and a second pull wire, the first pull wire being attached to thefirst lever and the second pull wire being attached to the second lever.The first lever may be coupled to the second lever such that extendingthe first lever in a distal direction retracts the second lever in aproximal direction and extending the second lever in the distaldirection retracts the first lever in the proximal direction. Thecatheter may not include a visualization member or lumen capable ofreceiving an endoscope. The catheter may include a stone trap in-linebetween the vacuum lumen of the handle portion and the vacuum source,the stone trap configured to collect stones removed via the vacuum lumenof the tube portion. The catheter may have a diameter of a distalopening in the vacuum lumen is smaller than a maximum inner diameter ofthe vacuum lumen. The catheter may have an inner diameter of the vacuumlumen tapers from proximal to distal over at least a portion of thevacuum lumen's length.

In a further aspect of the invention, disclosed herein is a method ofremoving kidney stones from a kidney of a patient. The method includesinserting a steerable catheter through the urethra, bladder, and ureterand into the kidney of the patient and inserting a distal portion of thecatheter into a first calyx of the kidney. The catheter has a vacuumlumen and an irrigation lumen. The vacuum lumen may have a diametergreater than 2 mm. The vacuum lumen and irrigation lumen have openingsat a distal end of the catheter. The irrigation lumen is in fluidcommunication with a fluid source and the vacuum lumen is in fluidcommunication with a vacuum source. The method further includesproviding fluid communication between the vacuum lumen and ambient airoutside of the patient. While fluid communication is provided betweenthe vacuum lumen and ambient air outside of the patient, irrigationfluid is continuously provided through the irrigation lumen and out ofthe irrigation lumen distal end into the first calyx until irrigationfluid returns through the vacuum lumen to outside of the patient. Afterthe irrigation fluid returns through the vacuum lumen to outside of thepatient, the fluid communication between the vacuum lumen and ambientair outside of the patient is terminated such that the vacuum sourceprovides negative pressure to the vacuum lumen. The method furthercomprises bending the distal portion of the catheter within the firstcalyx in a first bending direction by manipulating a steering memberoutside of the patient and removing one or more kidney stones from thefirst calyx to outside of the patient by aspiration of the kidney stonethrough the vacuum lumen. After removing the one or more kidney stonesfrom the first calyx, fluid communication between the vacuum lumen andambient air outside of the patient is reestablished. The method furtherincludes removing the distal portion of the catheter from the firstcalyx and inserting it into a second calyx of the kidney without use ofa guidewire or endoscope. The method further includes providingirrigation fluid through the irrigation lumen and out of the irrigationlumen distal end into the second calyx. The fluid communication betweenthe vacuum lumen and ambient air outside of the patient is terminatedsuch that the vacuum source provides negative pressure to the vacuumlumen while the distal portion of the catheter is in the second calyx.The method further includes bending the distal portion of the catheterwithin the second calyx by manipulating the steering member outside ofthe patient. All of the steps of the method are conducted without anydirect visualization from within the kidney.

One or more of the steps may be conducted with indirect visualizationfrom outside the patient. The indirect visualization may be fluoroscopy.

In some embodiments, irrigation fluid may be continuously providedthrough the irrigation lumen while the distal portion of the catheter isremoved from the first calyx and inserted into the second calyx. Afterinserting the distal portion of the catheter into the second calyx, themethod may include continuously providing irrigation fluid through theirrigation lumen and out of the irrigation lumen distal end into thesecond calyx until irrigation fluid returns through the vacuum lumen tooutside of the patient. The step of terminating the fluid communicationbetween the vacuum lumen and ambient air outside of the patient when thedistal portion of the catheter is in the second calyx may be performedafter the irrigation fluid returns from the second calyx through thevacuum lumen to outside of the patient. The method may further includeinserting the distal portion of the catheter into one or more additionalcalyces and providing irrigation fluid through the irrigation lumen andout of the irrigation lumen distal end into the one or more additionalcalyces. The fluid communication between the vacuum lumen and ambientair outside of the patient may be terminated such that the vacuum sourceprovides negative pressure to the vacuum lumen while the distal portionof the catheter is in the one or more additional calyces. The method mayfurther include bending the distal portion of the catheter within theone or more additional calyces by manipulating the steering memberoutside of the patient. The first calyx, second calyx, or one or moreadditional calyces may include a calyx within the lower pole of thekidney.

After bending the distal portion of the catheter within the first calyxand while the vacuum source provides negative pressure to the vacuumlumen, the method may include rotating the catheter in a first rotationdirection, bending the distal portion of the catheter within the firstcalyx in a second bending direction opposite the first bendingdirection, and rotating the catheter in a second rotation directionopposite the first rotation direction. Rotating the catheter in thefirst direction may include rotating the catheter approximately 180degrees in the first direction. Bending the distal portion of thecatheter in the second bending direction may include bending thecatheter such that a distal tip of the catheter is returned toapproximately the same position it was in before rotating the catheterin the first direction. Rotating the catheter in the second directionmay include rotating the catheter approximately 180 degrees in thesecond direction such that the distal tip of the catheter has traced asubstantially circular trajectory.

The method may further include removing one or more kidney stones fromthe second calyx to outside of the patient by aspiration of the kidneystone through the vacuum lumen. Removing the distal portion of thecatheter from the first calyx may be performed while terminating thefluid communication between the vacuum lumen and ambient air outside ofthe patient such that the vacuum source provides negative pressure tothe vacuum lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example of a kidney stone removal device.

FIG. 2A schematically depicts the anatomy of the human urinary tract.

FIG. 2B schematically depicts the anatomy of the human kidney.

FIGS. 3A-3B schematically depict an example of a distal end of acatheter comprising a vacuum tube and an irrigation tube. FIG. 3Adepicts a cross section taken along the longitudinal axis. FIG. 3Bdepicts a cross section intersecting the longitudinal axis.

FIGS. 4A-4G schematically depict various examples of lateral aspirationports.

FIGS. 5A-5H schematically depict various cross sections of a multi-lumenvacuum tube in which the various lumens may be used for aspiration,irrigation, and/or delivery of other devices.

FIGS. 6A-6C schematically depict various examples a cross section of acatheter comprising a vacuum tube and an irrigation tube.

FIGS. 7A-7B schematically depict examples of the dimensions, durometers,and other parameters of a vacuum tube used as the main body of a removaldevice catheter.

FIGS. 8A-8B schematically depict an example of a removal device handle.FIG. 8A illustrates a side view. FIG. 8B illustrates a cross section ofthe side view illustrated in FIG. 8A.

FIG. 9 schematically depicts a side view of another example of a devicehandle comprising a finger port.

FIGS. 10A-10B schematically illustrate device components that may beused with pull wires for steering a steerable portion of the catheter.FIG. 10A illustrates an example of a handle comprising levers formanipulating two pull wires. FIG. 10B illustrates a pull wire ring usedto introduce pull wires to the catheter.

FIGS. 11A-11F schematically illustrate another example of a devicehandle configured to operate pull wires. FIG. 11A illustrates aperspective view of the handle. FIG. 11B illustrates a side view of thehandle. FIG. 11C illustrates a cross section of the side view depictedin FIG. 11B. FIG. 11D illustrates a top view of the handle. FIG. 11Eillustrates a front view of the lever used to control the pull wires.FIG. 11E illustrates a cross section of a distal portion of the devicehandle including pull wires.

FIG. 12 schematically illustrates another example of a handle whichcomprises three fluid ports.

FIGS. 13A-13W schematically depicts cross sections and distal end viewsof irrigation lumens and catheters comprising irrigation lumens, whichmay include nozzles for altering irrigation streams.

FIGS. 14A-14C schematically depicts various arrangements of irrigationstreams relative to the direction of suction at the distal end of acatheter.

FIGS. 15A-15F schematically depict various examples of configurations ofcatheters comprising irrigation and aspiration.

FIGS. 16A-16E schematically depict various movements or ranges or motionthe distal end of the catheter may be configured to perform.

FIGS. 17A-17E schematically depict various examples of a removal devicecomprising a catheter comprising at least aspiration and a secondarydevice positioned alongside the catheter on a safety guidewire. FIG. 17Aillustrates the catheter and safety guidewire. FIG. 17B illustrates thecatheter and an ancillary irrigation tube. FIG. 17C illustrates thecatheter and a shield device in an expanded configuration. FIG. 17Ddepicts the catheter and a shield device configured to wrap around thecatheter. FIG. 17E depicts the catheter and a shield device in acollapsed configuration.

FIGS. 18A-18B illustrate an example of a distal end of a removal devicecomprising aspiration through a lateral aspiration port. FIG. 18Adepicts a perspective view of the distal end. FIG. 18B depicts a sideview of the distal end adjacent a ruler.

FIGS. 19A-19H schematically illustrate various positions of guide wires,delivery sheaths, and removal device catheters within a kidney.

FIGS. 20A-20D schematically illustrates the dimensions and configurationof an example of an obturator configured to be used with the removaldevice. FIG. 20A illustrates a side view of the obturator. FIG. 20Billustrates a distal end view of the obturator. FIG. 20C illustrates across section of a proximal end of the obturator/introducer. FIG. 20Dillustrates a cross section of a distal end of the obturator/introducer.

FIGS. 21A and 21B schematically depict another example of a removaldevice handle. FIG. 21A illustrates a side view. FIG. 21B illustrates across section of the side view illustrated in FIG. 21A.

DETAILED DESCRIPTION

Disclosed herein are systems, devices, and methods for the guidedremoval of objects in vivo. In particular, the systems, devices, andmethods may be adapted to traverse compact areas, such as the urinarytract, and to remove debris, such as kidney stones or fragments ofkidney stones, via aspiration through a vacuum tube. As used herein, theterm “kidney stones” may refer to fragments of kidney stones, includingfragments that have been created by therapeutic fracturing of kidneystones, such as with the device described herein or by another device.

FIG. 1 illustrates an image of an example of a removal device 100. Insome embodiments, a removal device 100 comprises a catheter 102configured to navigate the urinary tract. FIG. 2A schematically depictsanatomical structures of the urinary tract. FIG. 2B schematicallydepicts the anatomy of the kidney. The catheter 102 may be configuredfor introduction through the urethra and may be configured to extendthrough the bladder, through the ureter, and into the kidney. The kidneymay be comprised of three poles —an upper pole, middle pole, and lowerpole—that approximately correspond to three major calyces. The cathetermay have a proximal end 104 and a distal end 106. The catheter maydefine a longitudinal axis extending form the proximal end 104 to thedistal end 106. The distal end 106 may be configured to extend into thekidney as far as the major or minor calyces of the kidney. The proximalend 104 may be configured to remain outside the body. The proximal end104 may comprise a handle 200 for a user to hold the catheter 102. Thehandle 200 may comprise one or more grips for facilitating the holdingand manipulation of the catheter 102 by the user. The handle 200 may beused to advance and/or retract the catheter 102 through the urinarytract or other physiological tract. The handle 200 may comprise one ormore controls for controlling the operation of the catheter, such asirrigation, suction/aspiration, and/or movement, such as rotation,advancement, retraction, and/or lateral movement of the catheter (e.g.,a distal portion), which may be steerable.

FIGS. 3A-3B schematically illustrates an example of a distal end 106 ofthe catheter 102. FIG. 3A depicts a side view of a cross-section of thedistal end 106 of the catheter 102 along the longitudinal axis. FIG. 3Bdepicts a cross-section orthogonal to the longitudinal axis of thecatheter 102 near the distal end 106, but proximal to a nozzle,described elsewhere herein. The catheter 102 may comprise a vacuum tube110. In some embodiments, the vacuum tube 110 may constitute the mainbody of the catheter 102. The vacuum tube 110 may comprise a sidewall112 and a vacuum lumen 114 formed within the inner diameter of thesidewall 112. The sidewall 112 may be substantially cylindrical inshape. The size and shape of the vacuum lumen 114 may be configured foraspiration of debris, such as kidney stones. In some embodiments, thesize (e.g., diameter) of the vacuum lumen may be maximized, as describedelsewhere herein, to optimize the removal of larger kidney stones orother debris. The vacuum lumen 114 may extend to the proximal end 104 ofthe catheter 102 or at least to a proximal portion of the catheter 102configured to be positioned outside of the body, such that debris may beremoved from the body through the vacuum lumen 114.

The vacuum tube 110 may comprise an open distal face, such that thedistal face of the vacuum tube 110 forms an aspiration port 116 in fluidcommunication with the vacuum lumen 114 through which debris may enterthe vacuum lumen 114. Suction may be provided to the vacuum lumen 114 bycoupling a proximal end of the vacuum lumen 114 to a source of negativepressure (e.g., a wall suction outlet, a negative pressure pump, or anyother suitable means known in the art). In some embodiments, the distalface may be partially closed and/or a nozzle 150 may be formed at and/oron the distal end of the vacuum tube 110. In some embodiments, thenozzle 150 may form one or more apertures or aspiration ports 116 on thedistal face of the vacuum tube 110 that are smaller in cross-sectionalarea than the area formed by the inner diameter of the sidewall 112along the length of the catheter 102. Maximizing the size (e.g., thecross-sectional area) of the one or more aspiration ports 116 mayfacilitate removal of larger debris from the body within a physiologicalspace, such as the urinary tract, which may restrict the overalldiameter of the catheter 102.

One or more aspiration ports 116 may, additionally or alternatively, beformed by lateral apertures in the sidewall 112 of the vacuum tube 110.FIGS. 4A-4G schematically depict various examples of possiblearrangements of aspiration ports. Aspiration ports 116 formed in thesidewall 112 may face a lateral direction, substantially orthogonal tothe longitudinal direction of the catheter 102 over the length in whichthe ports are formed. Any of the examples depicted may also include oneor more distal-facing aspiration ports 116 formed in the distal face ofthe catheter 102 or may comprise no distal facing aspiration ports 116.In some embodiments, one or more lateral aspiration ports 116 may beformed in the sidewall 112 along a distal length of the vacuum tube 110(e.g., the last 50 mm, the last 30 mm, the last 25 mm, the last 20 mm,the last 15 mm, the last 10 mm, the last 5 mm, more than the last 50 mm,or less than the last 5 mm of the vacuum tube 110). In some embodiments,the catheter 102 may only comprise lateral aspiration ports 116 and thedistal face of the catheter may be closed. In some embodiments, thedistal face may be substantially rounded, domed, bullet-shaped, and/orcomprise another atraumatic configuration. Aspiration ports 116 may beformed in a non-flat (e.g., rounded) distal face and may face a distaldirection, a lateral direction, or a direction there between.

In some embodiments, the aspiration ports 116 may be substantiallycircular in shape. In some embodiments, the aspiration ports 116 may beother shapes (e.g., ovoid, rectangular, etc.). In some embodiments, thediameter of an aspiration port 116 may be 1 mm, 2 mm, 3 mm, 4 mm, 5 mm,6 mm, 7 mm, 8 mm, 9 mm, 10 mm, or more than 10 mm. The removal device100 may be sized to remove stones or other debris as large as 0.5 mm,0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 3mm, 4 mm, 5 mm, or more than 5 mm. The circumferential span of anaspiration port 116 may comprise approximately less than 5%, 5%, 10%,20%, 25%, 30%, 40%, 50%, or more than 50% of the circumference of thevacuum tube 110. In embodiments comprising a plurality of lateralaspiration ports 116, one or more aspiration ports 116 may be spacedalong a length of the vacuum tube 110 and/or one or more aspirationports 116 may be axially aligned and spaced across the circumference ofthe vacuum tube 110 (e.g., offset by 45 degrees, 90 degrees, 180degrees, etc.). One or more aspiration ports 116 which are axiallyspaced may be circumferentially aligned or they may be circumferentiallyoffset (e.g., offset by 45 degrees, 90 degrees, 180 degrees, etc.).Circumferentially offset aspiration ports 116 may somewhat overlap inthe circumferential direction or may not overlap at all. In embodimentscomprising multiple aspiration ports 116, the aspiration ports 116 maycomprise the same or different shapes and/or dimensions. One or moreaspiration ports may be positioned at a distal corner of the catheter102 such that it opens in both a distal-facing and lateral-facingdirection (e.g., FIG. 4G).

In some embodiments, as described elsewhere herein, an externalcomponent may surround the vacuum tube 110 (e.g., an irrigation tube130). In some embodiments comprising an external component, lateralaspiration ports 116 may be positioned distally of a distal end of theexternal component or the lateral aspiration ports 116 may extendthrough the external component. For example, the external component maycomprise an aperture of the same size as the aperture formed in thevacuum tube 110 and the external component may be sealed to vacuum tube110 around the aperture such that the aspiration port 116 extendsthrough the sidewall of the vacuum tube 110 and the sidewall of theexternal component.

In some embodiments, the catheter 102 may comprise more than one vacuumtube 110 and/or a single vacuum tube 110 may be formed with more thanone vacuum lumens 114. For example, the sidewall 112 may branch andextend inward to internally divide the vacuum tube 110 into multiplelumens of the same or different shape and/or cross-sectional areas).FIGS. 5A-5H schematically depict various examples of a multi-lumenvacuum tube 110 formed by the sidewall 112. The sidewall 112 may extendinto the vacuum lumen 114 to form one or more vacuum lumens 114 adjacentthe inner diameter of the vacuum tube 110 or the sidewall 112 may extendoutward to form one or more vacuum lumens 114 adjacent the outerdiameter of the vacuum tube 110. In some embodiments, the thickness ofthe sidewall 112 may be sufficient such that vacuum lumens 114 may beformed in the sidewall, extending axially along the length of the vacuumtube 110, without altering the shape (e.g., cylindrical) of the vacuumtube 110 and central vacuum lumen 114. In some implementations, one ormore vacuum lumens 114 may be too small in size (e.g., cross-sectionalarea or diameter) to allow passage of a kidney stone, but may generatesuction which is useful for moving a kidney stone or other debris towardan aspiration port 116 which is configured to remove matter from thephysiological space. A vacuum lumen 114 may be cylindrical or otherwisesubstantially round in shape. A vacuum lumen 114 may be non-cylindricalin shape. In some embodiments, one or more vacuum lumens 114 areelongate in shape. In some embodiments, the vacuum lumen includes ataper of its inner diameter from proximal to distal along a portion orthe entire length of the vacuum lumen. For example, in some embodiments,the vacuum lumen includes a tapered distal tip such that the diameter ofthe aspiration port is smaller than the inner diameter of the vacuumlumen. This feature can advantageously reduce clogging of the vacuumlumen with debris (e.g., by reducing the size of the kidney stones thatcan enter the vacuum lumen). In other embodiments, the vacuum lumenincludes a longer taper from proximal to distal, for example, alongsubstantially the entire length of the vacuum lumen. In someembodiments, the diameter of the aspiration port is from 0.05 mm to 0.5mm, 0.05 mm to 0.3 mm, 0.05 mm to 0.2 mm, 0.05 to 0.1 mm, or 0.08 mm to0.2 mm smaller than the maximum inner diameter of the vacuum lumen. Insome embodiments, the inner diameter of the vacuum lumen increasescontinually from the distal end to the proximal end. In someembodiments, the inner diameter of a vacuum lumen within a handle towhich the vacuum lumen is coupled also increases from distal to proximalwithin the handle. Thus, in some embodiments, the inner diameter of thecombined catheter and handle vacuum lumens continuously increases fromdistal to proximal such that the minimum inner diameter is at the distaltip of the catheter, and the maximum inner diameter is at a fluid porton the handle, which is to be coupled to a vacuum source.

The catheter 102 may comprise one or more irrigation lumens 134 forproviding irrigation at or near the distal end 106 of the catheter 102.Irrigation may be particularly beneficial for use in the kidney (e.g.,for removing kidney stones). Irrigation may dislodge kidney stones fromtissue and/or may provide enough buffer/cushion/barrier to prevent thesuction from sucking tissue into the aspiration port 116, which mayocclude the vacuum lumen 114 and inhibit aspiration of kidney stones.Suction of delicate kidney tissue into contact with the catheter 102 maypose a safety hazard, as the suctioning may cause damage or irritationof the tissue (e.g., may cause bleeding). For this reason, it isconventional not to use suctioning within the kidney withoutureteroscope or direct visualization, especially within the calyces, toremove kidney stones. Providing a sufficient level of irrigation(relative to the level of suctioning) which inhibits, reduces, and/orprevents suctioning of kidney tissue may improve the safety and/orefficacy of the removal device 100. This safety feature may beparticularly advantageous for blind procedures which do not utilizedirect visualization. Providing too much irrigation may, in someembodiments, result in over-pressurization of the kidney which can haveadverse consequences. Providing a valve or port establishing fluidcommunication between the ambient atmosphere and the kidney may reducethe chance of or prevent the risk of overpressurization. Each irrigationlumen 134 may terminate in one or more openings, which serve asirrigation ports 136 in fluid communication with the irrigation lumen134 through which an irrigation fluid may be delivered from theirrigation lumen 134 into the body. In some embodiments, the distal endface of the irrigation lumen 134 may be open such that the opening formsan irrigation port 136. In some embodiments, the distal end of theirrigation lumen 134 may be partially closed but may comprise one ormore apertures forming one or more irrigation ports 136 and/or a nozzlemay be incorporated into the opening, as described elsewhere herein, orat the opening, such as the nozzle 150 depicted in FIG. 3A.

In some embodiments, the one or more irrigation lumens 134 may be formedby one or more irrigation tubes 130, which may be separate structuresfrom the vacuum tube 110. FIGS. 6A-6C schematically depict variousexamples of arrangements of vacuum tubes 110 and irrigation tubes 130within the catheter 102. The irrigation tubes 130 may be positionedinternally within the vacuum tube 110 (FIG. 6A), externally adjacent tothe vacuum tube 110 (FIG. 6B), and/or externally surrounding the vacuumtube 110 (FIG. 6C as well as FIGS. 3A and 3B). The irrigation tubes 130may be rigidly affixed to the vacuum tube at one or more points (e.g.,along the entire length of the catheter 102), may be coupled to thevacuum tube 110 by the handle 200, or may be uncoupled. In someembodiments, the one or more irrigation lumens 134 may be formed withinthe sidewall of the vacuum tube 110. Any of the lumens depicted in FIGS.5A-5H may be used alternatively as irrigation lumens 114. In someembodiments, lumens of smaller size (e.g., cross-sectional area) may bemore suited for providing irrigation than for aspiration, depending onthe size of the debris being removed. For example, a plurality ofirrigation lumens 134 may be formed in a cylindrical sidewall of thevacuum tube 110 such that a plurality of irrigation ports 136circumferentially surrounds the aspiration port 116 (e.g., FIG. 5E).

In some embodiments, lateral irrigation ports 136 may be formed along anirrigation lumen 134, in addition to or alternatively to a distalopening irrigation port 136, in the same manner in which lateralaspiration ports 116 may be formed (FIGS. 4A-4G). An irrigation lumen134 may be substantially cylindrical in shape. An irrigation lumen 134may be non-cylindrical in cross-sectional shape. In some embodiments,the irrigation lumen 134 may run parallel with the longitudinal axis ofthe catheter 102. In some embodiments, the irrigation lumen 134 may notrun parallel with the longitudinal axis of the catheter 102 and/or mayrun parallel along lengths of the catheter 102 but experience curves orother changes in direction, such as near the irrigation port 136. Insome embodiments, one or more irrigation lumens 134 are elongate incross-sectional shape. For example, the sidewall of the vacuum tube 110may comprise thin irrigation lumens 134 that form arcs expandingapproximately less than 5%, 5%, 10%, 20%, 25%, 33%, 50%, or greater than50% of the circumference of the vacuum tube 110 (e.g., FIGS. 5F and 5G).The one or more irrigation lumens 134 may be coupled at their proximalends to a source of pressurized irrigation fluid for forcing irrigationfluid through the irrigation lumens 134, such as a syringe, a washbottle, a positive displacement pump, an IV bag, or any other suitablefluid irrigation source known in the art (e.g., a single action pumpsystem such as provided by Boston Scientific). In embodiments comprisingan electronic pump, a controller comprising appropriate software may beused to control the operation of the pump. In some embodiments, theirrigation fluid may comprise water, saline, or any otherphysiologically suitable fluid.

In some embodiments, additional lumens may be formed along the length ofthe catheter 102. For example, lumens may be configured for receiving anintroducer or obturator, a visualization device such as an endoscope(e.g., a ureteroscope), and/or a navigation mechanism such as aguidewire. In some embodiments, a specific lumen may be formed for theintroduction of each additional device from a separate tube structure orfrom the sidewall of an existing lumen as described with respect to thevacuum lumens 114 and/or irrigation lumens 134. In some embodiments, avacuum lumen 114 and or an irrigation lumen 134 may be configured toreceive one or more of these devices (e.g., configured in size and/orshape). For example, the vacuum lumen 114 may be configured to receivean introducer and/or an irrigation lumen 134 may be configured toreceive a guidewire. The ancillary devices may be configured to be usedwith the catheter 102 disclosed herein. For instance, an introducer maybe sized and shaped to be received in and to fill the cross-sectionalarea of a vacuum lumen 114 in which an irrigation lumen 134 extends intothe otherwise cylindrical lumen. These devices may be removed from thelumen prior to starting aspiration and/or irrigation, such as after thecatheter 102 has been properly positioned in the ureter or kidney. Insome embodiments, the catheter 102 comprising one or more vacuum lumens114 and optionally one or more irrigation lumens 134, may be configuredto be received in an outer sheath, such as a delivery sheath. The outersheath may be optimized for introduction of the catheter 102 and/orother devices into the urinary tract. For example, the outer sheath maycomprise a hydrophilic and/or lubricious coating, which facilitatesinsertion of the sheath into the urethra. The outer sheath may partiallydilate the urethra. The outer sheath may protect the urethra and otherportions of the urinary tract or other body lumen from damage asinstruments are advanced within and/or retracted through the outersheath. In some embodiments, the outer sheath may help navigate internalinstruments through the body lumen, particularly if the internalinstrument is relatively more flexible than the outer sheath. The outersheath may comprise a coil and/or wire braid, as described elsewhereherein with respect to catheter 102, for providing enhanced structuralintegrity. The outer sheath may comprise a radiopaque marker or befabricated from radiopaque materials for visualization duringfluoroscopy. The catheter 102 may also be radiopaque or compriseradiopaque materials, such that it may be visualized under fluoroscopy.

Embodiments of the catheter 102 disclosed herein may comprise and/or maybe used with any of the components disclosed in U.S. Patent PublicationNo. 2017/0319776 to Eisner et al., entitled “System and Method forGuided Removal from an In Vivo Subject,” and filed Jul. 13, 2017, whichis hereby incorporated by reference in its entirety. Also, the variouscomponents disclosed herein may be arranged in the same or similarfashion to the components in U.S. Patent Publication No. 2017/0319776.For example, the irrigation lumens 134 and vacuum lumens 114 maycomprise any of the configurations disclosed therein.

In some embodiments, the vacuum tube 110 may form the main body of thecatheter 102. The vacuum tube 110 may comprise a wire braid and/or coilas is known in the art. The braid and/or coil may help preserve thestructural integrity of the catheter 102 under pressure (e.g., preventkinking and/or collapsing of the lumen) and/or may help tailor theflexibility/rigidity of the catheter 102. The braid and/or coil mayextend the entire length of the catheter 102 or may extend only apartial length of the catheter 102. For example, the vacuum tube 110 maycomprise a wire ribbon. The wire ribbon may be stainless steel (e.g.,300 series stainless steel wire ribbon). The wire ribbon may beapproximately 0.001 in by 0.005 inch. The wire ribbon may have a 0.010inch pitch. The wire ribbon may be at least a 16 carrier, 24 carrier, or28 carrier braid. The wire ribbon may be braided 1 over 2 under 2. Thewire ribbon may comprise approximately 80 ppi. The wire ribbon may bebraided 2 over 2 with 2 to 3 ends per carrier. The wire ribbon may bebraided 2 over 1. The wire ribbon may be braided in a tri-axial pattern.The braid and/or coil may be sandwiched between an inner layer (e.g.,Propel® or polytetrafluoroethylene (PTFE) inner liner) and an outerlayer (e.g., polyether block amide such as PEBAX®) of the vacuum tube110 sidewall 112. The outer layer may comprise barium sulfate (BaSO₄),in amounts such as about 40%. In some embodiments, the inner layer maybe between about 0.012 to about 0.016 inches thick. The braid or coilmay extend substantially from the proximal end 104 to the distal end 106of the catheter 102, substantially along a proximal portion of thecatheter 102, substantially along a distal portion of the catheter 102,or along an intermediate section of the catheter 102. In someembodiments, the inner layer and/or the outer layer may be formed ofsegments comprising variable durometers. The durometer may decrease in adistal direction such that the catheter 102 becomes progressively moreflexible toward the distal end, which may be advantageous for navigatingmore tortuous pathways, such as the calyces of the kidney (e.g., bendingthe distal end 106 of the catheter 102 to reach into the lower pole ofthe kidney). In some embodiments, the braid may transition into a coilor vice-versa. The density of the wire braid (e.g., picks/length) orcoil (e.g., pitch) may be used to modulate the flexibility/rigidity ofthe catheter 102 along its length. In some embodiments, the durometersof the various segments may be configured for providing specific amountsof curvature in steerable portions of the catheter 102, as describedelsewhere herein. For example, the catheter 102 may comprise one or morecurvable portions capable of achieving a radius of curvature of about5.0 cm, 4.75 cm, 4.5 cm, 4.25 cm, 4.0 cm, 3.75 cm, 3.5 cm, 3.25 cm, 3.0cm, 2.75 cm, 2.5 cm, 2.25 cm, 2.0 cm, 1.75 cm, 1.5 cm, 1.25 cm, 1.0 cm,0.75 cm, 0.5 cm, less than 0.5 cm, or a value in a range definedtherebetween. For instance, a distal portion of the catheter 102 may becapable of achieving a curvature such that the distal tip may bepositioned within the lower calyx. In some embodiments, the catheter 102may comprise a durometer of about 50D, 55D, 60D, 63D, 65D, 70D, 72D,75D, 80D, 90D, 100D, less than 50D, greater than 100D, or a durometerselected from any range there between at the proximal end 104. In someembodiments, the catheter 102 may comprise a durometer of about 10D,15D, 20D, 25D, 30D, 35D, 40D, 45D, 50D, less than 10D, greater than 50D,or a durometer selected from any range there between at the distal end106. In some embodiments, the catheter 102 may comprise one or moreintermediate durometers, such as durometers of about 35D, 40D, 45D, 50D,55D, less than 35D, greater than 55D, or a durometer selected from anyrange there between. The intermediate durometer or durometers may be anamount or amounts between the proximal durometer and the distaldurometer. The changes in durometer may be accomplished by materialselection and/or thickness of one or more layers of the catheter (e.g.,the outer layer), wherein thicker layers of the same material aregenerally stiffer than thinner layers of the same material. The catheter102 may be configured to prevent kinking over its entire length or atleast along a distal portion of the length. For example, the catheter102 may be kink-free along at least the distal 50 mm of the length whenforming a bend with a radius of curvature of 13 mm.

FIGS. 7A-7B schematically depict dimensions and other parameters of avacuum tube 110 used to form the catheter 102. The catheter 102 maycomprise three or more segments with decreasing durometer from aproximal to distal direction. For example, as shown in FIG. 7A, thecatheter 102 may comprise a proximal 63D segment 105, an intermediate35D segment 107, and a distal 25D segment 109. In another example, asshown in FIG. 7B, the catheter 102 may comprise a proximal 63D segment105, an intermediate 55D segment 107, and a distal 35D segment 109. Insome embodiments, the intermediate segment 107 may be omitted. In someembodiments, primarily for kidney stone removal, the total length of thecatheter 102 may be at least about 30 cm, 35 cm, 40 cm, or longer than40 cm. The length may be longer for male subjects than for female,subjects, by approximately 6-8 inches. In some embodiments, the lengthof the proximal segment 105 may be substantially greater than the lengthof the intermediate segment 107 and/or the length of distal segment 109,or even the length of the intermediate segment 107 and the distalsegment 109 combined. For instance, the length of the proximal segment105 may be about 25 inches and the length of the intermediate segment107 and distal segment 109 may be about 6 inches combined (e.g., 5inches and 1 inch, 4.5 inches and 1.5 inches, 4 inches and 2 inches, 3inches and 3 inches, 2 inches and 4 inches, 1 inch and 5 inches, etc.).In some embodiments, the intermediate segment 107 may correspond to agenerally flexible segment configured to bend for navigation into thekidney. In some embodiments, the distal segment 109 may correspond to asteerable segment configured to be articulated by pull wires 230 orother steering means. The pull wires 230 described elsewhere herein maybe attached, for example, to either the distal section 109, theintermediate section 107, or both. The pull wires 230 may extend fromthe distal section 109 along the length of the vacuum tube to extendbeyond the proximal end of the vacuum tube for engagement with a controlfeature. In some embodiments, the pull wires 230 are embedded within thewall of the vacuum tube. In some embodiments, the pull wires 230 extendthrough tubes 111, which are embedded within the wall of the vacuumtube. In some embodiments, the tubes 111 comprise PTFE. In someembodiments, the intermediate section 107 may be omitted. The distalsection 109 may be between about 1-3 inches long.

The steerable segment may be very flexible such that the steerablesegment may be actively bent to form tight curves (e.g., 180 degreebends or more). In some embodiments, the steerable segment may be bentto form curves equal to or greater than about 90 degrees, greater thanabout 100 degrees, greater than about 110 degrees, 120 degrees, 130degrees, 140 degrees, 150 degrees, 160 degrees, 170 degrees, 180degrees, 200 degrees, 240 degrees, 270 degrees, or more than 270degrees. The catheter 102 may be configured to allow efficient stonetransport through the vacuum lumen 114 even under these degrees ofbending (e.g., without kinking). The steep drop-off in durometer, suchas between a distal 109 and proximal 105 segment (including or notincluding intermediate segments 107) may promote a high degree ofbendability at the transition configured for forming tight bends havingsmall radii of curvatures. In embodiments, in which the catheter 102comprises an outer tube surrounding the vacuum tube 110, such as aconcentric irrigation tube 130, described elsewhere herein, the outertube may also have a drop-off in durometer. The drop-off in durometer ofthe outer tube may promote bending of the outer tube along with thecontrolled bending of the vacuum tube 110. The drop-off may bepositioned along the length of the catheter at the same point as thedrop off in the vacuum tube 110. In some embodiments, the durometers ofthe outer tube may match the durometers of the vacuum tube 110 alongequivalent lengths. In some embodiments, the durometers of the outertube may be generally less than that of the vacuum tube 110 alongequivalent lengths. For instance, the outer tube may have a proximalsection having a durometer of about 55D and a distal section having adurometer of about 35D. In some embodiments, the distal section 109 mayhave a durometer less than about 35D. In some embodiments, the steerablesegment is about 0.5 inches to about 6 inches long, about 0.8 inches toabout 5 inches long, about 1 inch to about 4 inches long, or about 1inch to about 3 inches long. In some embodiments, the inner diameter ofthe catheter 102 and/or vacuum tube 110 may be about 0.07 inches, 0.075inches, 0.08 inches, 0.085 inches, 0.09 inches, 0.095 inches, 0.096inches, 0.097 inches, 0.098 inches, 0.099 inches, 0.1 inches, 0.105inches, 0.11 inches, 0.12 inches, 0.13 inches, 0.14 inches 0.15 inches,0.175 inches, 0.2 inches, less than 0.07 inches, greater than 0.2inches, or a diameter in any range defined there between. In someembodiments, the inner diameter of the vacuum tube 110 is greater than0.1 inches, greater than 0.13 inches, greater than 0.14 inches, orgreater than 0.15 inches. In some embodiments, the inner diameter of thevacuum tube 110 is between 0.1 inches and 0.3 inches, between 0.13inches and 0.25 inches, between 0.14 inches and 0.23 inches, or between0.14 inches and 0.2 inches. The inner diameter may be at least about 5Fr 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14 Fr, 15 Fr, ormore than 15 Fr. In some embodiments, the outer diameter of the catheter102 and/or vacuum tube 110 may be about 0.09 inches, 0.095 inches,0.096, inches, 0.097 inches, 0.098 inches, 0.099 inches, 0.1 inches,0.11 inches, 0.12 inches, 0.13 inches, 0.133 inches, 0.14 inches, 0.15inches, 0.175 inches, 0.2 inches, 0.25 inches, less than 0.095 inches,greater than 0.25 inches, or a diameter in any range defined therebetween. The wall thickness of the of the catheter 102 and/or vacuumtube 110 may be about less than 0.005 inches, 0.005 inches, 0.006inches, 0.007 inches, 0.008 inches, 0.009 inches, 0.01 inches, 0.011inches, 0.012 inches, 0.013 inches, 0.014 inches, 0.015 inches, 0.016inches, 0.017 inches, 0.018 inches, 0.019 inches, 0.02 inches, 0.025inches, 0.03 inches, 0.04 inches, 0.05 inches, more than 0.05 inches, ora thickness from any range defined there between. The outer diameter maybe at least about 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 11 Fr, 12 Fr, 13 Fr, 14Fr, 15 Fr, 16 Fr, or more than 16 Fr. In some embodiments, the wallthickness is about 0.432 inches. In some embodiments, the wall thicknessis about 0.356 inches. In some embodiments, the wall thickness may berelatively thin or minimized in order to maximize the cross-sectionalarea and diameter of the vacuum lumen 114. The wall thickness may be asthin as possible while maintaining structural integrity sufficient toresist collapsing under vacuum pressure and/or kinking.

The example of the distal end 106 of the catheter 102 depicted in FIGS.3A-3B illustrates one possible configuration of a vacuum tube 110 and anirrigation tube 130. The vacuum tube 110 may comprise a cylindricalsidewall 112 and may terminate in a distal open face forming anaspiration port 116. The irrigation tube 130 may be configured toreceive the vacuum tube 110 as shown, forming an annular irrigationlumen 134 and an annular irrigation port 136 surrounding the vacuum tube110. The distal end of the irrigation tube 130 may extend distallybeyond the distal end of the vacuum tube 110 forming a nozzle 150, asdescribed elsewhere herein. The nozzle 150 may decrease in thickness asit extends distally. The nozzle 150 may comprise a decreasing outerdiameter and/or a decreasing inner diameter as it extends distally. Thenozzle may be relatively more flexible than the remaining length of theirrigation tube 130. In some embodiments, the irrigation tube 130 may berelatively more flexible and/or compressible than the vacuum tube 110.The irrigation tube 130 (i.e. the inner diameter or the inner and outerdiameter) may comprise a somewhat expandable diameter. For example, theirrigation tube 130 may comprise an unexpanded diameter when irrigationfluid is not forced through the irrigation lumen 134 and the pressurizedirrigation fluid may slightly expand the diameter of the irrigationlumen 134 or the diameter of the irrigation tube 130 altogether whenirrigation fluid is forced through the irrigation lumen 134. Theunexpanded diameter may be configured to fit closely around the outerdiameter of the vacuum tube 110. The unexpanded diameter may facilitateinsertion of the catheter 102 in the urethra or other constricted spaceof the body. The distal end of the vacuum tube 110 may be positionedfurther back in the proximal direction from the distal end of theirrigation tube 130 than as shown in FIG. 3A.

In some embodiments, the distal end of the vacuum tube 110 may beapproximately aligned with the distal end of the irrigation tube. Inother embodiments, the distal end of the vacuum tube 110 may bepositioned distally beyond the distal end of the irrigation tube 130.The irrigation tube 130 may be relatively soft (e.g., 35D) and may besofter than the vacuum tube 110. Positioning the distal end of theirrigation tube 130 proximally to the distal end of the vacuum tube 110may prevent or reduce the likelihood or degree of the irrigation tube130 buckling, collapsing, stretching, and/or sliding forward or backwardover the vacuum tube 110 when the vacuum tube 110 is bent. In someembodiments, the distal end of the irrigation tube 130 may be positionedat least approximately 1 mm from the distal end of the vacuum tube 110in an unbiased configuration. The distal end of the irrigation tube 130may be positioned at least distally enough such that it positionedbeyond a curve in the catheter and the irrigation is aligned in the samedirection as the aspiration. In some embodiments, the distal end of theirrigation tube 130 may be configured such that it does not advancewithin at least approximately 1 mm of the distal end of the vacuum tube110 upon bending the catheter 102. In some embodiments, the distal endof the irrigation tube 130 may be configured such that it does notadvance any further than approximately 1 mm from the distal end of thevacuum tube 130 upon bending of the catheter 102. In some embodiments,the distal end of the irrigation tube 130 may be configured such that itsits somewhere between approximately the distal end of the vacuum tube110 and approximately 1 mm proximally back from the distal end of thevacuum tube 110 during use. In some embodiments, the distal end of theirrigation tube 130 may be configured such that it sits somewherebetween approximately 1 mm back proximally from the distal end of thevacuum tube 110 and approximately 1 mm forward distally from the distalend of the vacuum tube 110 during use.

FIGS. 8A-8B schematically illustrate an example of a handle 202 attachedto a proximal end of the catheter 102. The handle 202 may include thesame or similar features as other handles described elsewhere herein.FIG. 8A depicts a side view of the handle 202. FIG. 8B depicts a crosssection of the side view depicted in FIG. 8A. The handle 202 may beconfigured for use with a catheter 102 such as that depicted in FIGS.3A-3B. The handle 202 may comprise a Y-shaped coupling 220 having twofluid ports 222. The fluid ports 222 may comprise hemostasis valves. Thefluid ports 222 may be configured to couple to luer-type connectors. Oneof the fluid ports 222 may be configured to be in fluid communicationwith the one or more vacuum lumens 114. One of the fluid ports 222 maybe configured to be in fluid communication with the one or moreirrigation lumens 134. The proximal end 138 of the irrigation tube 130may be positioned distally of the proximal end 118 of the vacuum tube110 within the handle 202. The handle 202 may include a shell or casing224. The shell or casing 224 may include a grip for grasping by theuser. The handle 202 may include a strain relief 226 for facilitatingtransfer of forces from the handle 202 to the catheter 102. The strainrelief 226 may extend partially into the shell or casing 224. The strainrelief 226 may tightly fit around an outer diameter of the catheter 102along a portion of the length of the catheter 102. In someimplementations, the catheter 102 may be axially translated in aproximal or distal direction by translating the handle 202 in acorresponding axial direction. In some implementations, the catheter 102may be rotated by rotating the handle 202. In some embodiments, thefluid port 222 into the vacuum lumen within the handle is positioned onthe proximal end of the handle 202 and the fluid port 222 into theirrigation lumen within the handle is position on the Y-branch of thehandle. In some embodiments, the vacuum lumen within the handle extendssubstantially straight from a distal portion of the handle 202 to theproximal end of the handle 202, for example from the coupling to thecatheter vacuum tube 110 to the proximal end of the handle. In someembodiments, the inner diameter of the vacuum lumen within the handletapers from proximal to distal, such that the inner diameter at theproximal end fluid port 222 is greater than the inner diameter at thecoupling to the catheter vacuum tube 110.

FIG. 9 schematically illustrates a side view of another example of ahandle 204. The handle 204 may include the same or similar features asother handles described elsewhere herein. In some embodiments, thehandle 204 may comprise a side opening or finger port 228. The fingerport 228 may be in fluid communication with the vacuum tube 110. Thefinger port 228 may be positioned anywhere along the length of thehandle. For example, the finger port 228 may be positioned 1 cm, 5 cm,10 cm, 15 cm, 20 cm, 25 cm, 30 cm, 40 cm, 50 cm, more than 50 cm fromeither the proximal or distal end of the handle 204. In someembodiments, the finger port 228 may be positioned/formed on thecatheter 102 (within the sidewall 112). In some embodiments, the fingerport may be positioned/formed on a suction line connected to the outletof the handle 204 (e.g., connected to a proximal end of the handle). Insome embodiments, the finger port 228 may be positioned on a lever orknob for manipulating a pull wire, as described elsewhere herein. Thelever or knob may comprise an internal passage joining the vacuum lumen114 and finger port 228 in fluid communication. When not occluded (e.g.,by a finger), the finger port 228 may also be in fluid communicationwith the ambient atmosphere such that any suction generated by thenegative pressure source does not provide a significant suction force atthe distal end of the vacuum tube 110. The finger port 228 mayadvantageously provide fluid communication between the kidney or otherphysiological area of interest via one or more aspiration ports 116 andthe ambient atmosphere. Doing so may effectively preventover-pressurization of the kidney, even when irrigation is applied. Thefinger port 228 may act as a pressure release valve, which may releasepressure from the kidney or equilibrate pressure within the kidney. Forexample, excess irrigation fluid may flow down the aspiration lumen 114and exit via the finger port 228 even absent the negative pressure ofsuction. Thus, in some embodiments, pressure between the inside of thekidney and the ambient atmosphere may be equilibrated during anon-suctioning period during which no suction is provided through theone or more aspiration ports 116 in fluid communication with the fingerport. In embodiments comprising multiple aspiration ports 116, some orall of the aspiration ports 116 may be in fluid communication with thefinger port 228. In some embodiments comprising multiple aspirationports 116, the aspiration ports 116 may be in fluid communication withmultiple finger ports 228. When a user wishes to provide suction throughthe catheter 102, the user may place a finger over the finger port 228,occluding the negative pressure source's fluid coupling with the ambientatmosphere and causing a suction force to be generated at the distal endof the vacuum tube 110. Removal of the user's finger may cause suctionto cease again. The finger port 228 may advantageously allow the user toquickly stop and start suction with a single finger on-demand (e.g.,instantaneously or virtually instantaneously), without having to let goof or rearrange his or her grip on the handle 204.

In some embodiments, a finger port 228 may similarly be used forproviding on-demand control over irrigation. In some embodiments, asingle finger port 228 may provide control over both suction andirrigation. For example, in one embodiment, occluding the finger port228 may begin suctioning and temporarily stop an otherwise continuousirrigation or vice-versa. In another embodiment, occluding the fingerport 228 may instantaneously begin suctioning and irrigation. Amechanical and/or hydrodynamic coupling between the vacuum tube and/or afluid port 222 in communication with the vacuum tube 110 and theirrigation tube 130 and/or a fluid port 222 in communication with theirrigation tube 130 may be used to synchronize the suction andirrigation in an appropriate manner. For example, in one embodiment thesuction provided by the negative pressure source when the finger port228 is occluded may collapse a collapsible portion of the irrigationtube 130 or a collapsible segment of a fluid port 222 proximal to theirrigation tube 130, thereby preventing the transfer of irrigation fluidto a distal end of the catheter 102. In another embodiment, the suctionprovided by the negative pressure source when the finger port 228 isoccluded may force open a valve (e.g., a one-way valve) which isblocking the flow of irrigation fluid. In some embodiments, the fingerport may comprise a pressable button. The pressable button may allow airflow through the finger port 228 and prevent suction when left unpressedand may either occlude (e.g., pinch) the irrigation passage when pressedor cause a valve to open within the irrigation passage when pressed.Other various mechanical arrangements are possible to suit any desiredconfiguration of control over aspiration and irrigation. In someimplementations, actuation of the finger port 228 or other control maynot start and stop suction and/or irrigation but may modulate the levelof suction and/or irrigation. For instance, a basal level of suctionand/or irrigation may be provided and the level may be transientlyincreased (e.g., pulsed) or transiently decreased (e.g., dampened) byactuation of the finger port 228.

In some embodiments, a portion of the length of the catheter 102, suchas a distal portion, may be steerable or articulable. Specifically, thecurvature of one or more portions of the steerable length may becontrollable such that a user is able to control, at least to an extent,the shape or curvature of the steerable portion as it extends from thehandle 200 or a non-steerable portion of the catheter 102. By adjustingthe curvature of a distal portion of the catheter 102, a user mayeffectively move the distal tip of the catheter 102 with some precisionthrough a prescribed volume of space without repositioning the proximalportion of the catheter 102. In some embodiments, the vacuum tube 110 isconfigured to be steerable. Steering the vacuum tube 110 maysimultaneously steer or control the configuration of portions of anyirrigation tubes 130 or surrounding sheaths that are coupled to thevacuum tube 110 and overlap the length of the steerable portion of thevacuum tube 110. In other embodiments, an irrigation tube 130 or boththe vacuum tube 110 and an irrigation tube 130 may be steerable. Invarious embodiments, steerable portion of the catheter 102 is steerableat angles greater than about 90 degrees, greater than about 100 degrees,greater than about 110 degrees, greater than about 120 degrees, greaterthan about 130 degrees, greater than about 140 degrees, greater thanabout 150 degrees, greater than about 160 degrees, greater than about170 degrees, or greater than about 180 degrees. In some embodiments, thesteerable portion of the catheter is steerable at angles up to about 90degrees, up to about 100 degrees, up to about 110 degrees, up to about120 degrees, up to about 130 degrees, up to about 140 degrees, up toabout 150 degrees, up to about 160 degrees, up to about 170 degrees, orup to about 180 degrees.

FIGS. 10A-10B schematically illustrate examples of components that maybe used for steering the catheter 102. FIG. 10A depicts a handle 206connected to the catheter 102 including two levers 232, each of which isconfigured to control a pull wire 230 attached to the steerable portionof the catheter 102. FIG. 10B depicts an example of a pull wire ring 234which may be attached to an outer circumference of the catheter 102 andis configured to introduce the pull wires 230 extending from the leversto the catheter 102.

One or more pull wires 230 may be used to control the steering orarticulation of the steerable portion of the catheter 102. In someembodiments, the pull wires 230 may be about 0.001 inch to about 0.005inch. In some embodiments, the pull wires 230 may be about 0.001 inch toabout 0.01 inch. For example, the pull wires 230 may be about 0.006inches. The pull wires may comprise stainless steel. In someembodiments, the pull wires 230 may have a circular cross-section. Insome embodiments, the pull wires 230 may have an oblong cross section(e.g., about 0.001 inch by 0.005 inch). A pull wire 230 may be rigidlyattached at one or more points along a section of the catheter 102 inwhich the pull wire 230 is configured to articulate. Proximal to theattachment point or points the pull wire 230 may be coupled to thecatheter 102 in a non-fixed manner such that the pull wire 230 is ableto glide or otherwise advance proximally and/or distally over the lengthof the catheter 102. In some embodiments, the pull wires 230 may beencased in an outer liner 111 (see FIG. 7B), such as apolytetrafluoroethylene (PTFE) tube. The PTFE tubes may comprise a wallthickness of about 0.001 to about 0.002 inches, in some embodiments. Theouter liner 111 may improve the gliding of the pull wire 230 along theadjacent length of the catheter 102. In some embodiments, the pull wires230 may extend along the outside of the vacuum tube 110. In someembodiments, the pull wires 230 may extend along an inside of the vacuumtube 110 (e.g., along a surface of the vacuum lumen 114). In someembodiments, the pull wires 230 may extend within the sidewall 112 ofthe vacuum tube 110. For instance, the pull wires 230 may extend in thespace between an inner layer and an outer layer of the vacuum tube 110,such as either inside of or outside of the braid or coil or within thebraid or coil (e.g., triaxially within the braid). In embodiments usingouter liner 111, the liner 11 may extend in the space between an innerlayer and an outer layer of the vacuum tube 111. In some embodiments,the pull wires 230 may extend all the way to the distal end of thecatheter 102 and/or to the distal end of the steerable portion of thecatheter 102. The pull wire 230 may be fixedly attached to the catheter102 at the distal end of the pull wire 230 or at one or more pointsproximal to the distal end of the pull wire 230. The pull wires 230 maybe coupled at a distal end to a pull ring formed in the sidewall 112 orcoupled to the sidewall 112. The pull ring may comprise stainless steel.In some embodiments, the pull ring may be positioned back from thedistal edge of the catheter 102. For example, the pull ring may be about0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm,less than 0.5 mm, more than 5 mm from the distal end of the catheter102, or some value in a range defined there between.

Placing tension on a pull wire 230 may cause the length of the pull wire230 aligned along the catheter 102 to shorten and may thereby cause thecatheter 102 to bend along the side of the catheter 102 to which thepull wire 230 is attached. The catheter 102 may bend along a portion ofthe length or the entire length proximal to the attachment point of thepull wire 230 (the steerable portion). The flexibility and/or gradientof flexibility of the catheter 102 along the steerable portion maydetermine the amount of curvature experienced along a particular lengthof the catheter 102 for a given amount of tension/contraction. In someembodiments, more than one pull wire 230 may be positioned along thesame side and may be fixedly attached to the catheter 102 at differentaxial points. Multiple pull wires 230 positioned along a single side mayfine-tune the curvature of bending. In some embodiments, multiple pullwires 230 may be positioned on different sides of the catheter 102(e.g., two pull wires positioned approximately 180 degrees from eachother relative to the circumference of the catheter). In embodimentscomprising multiple pull wires 230 on different sides of the catheter102, the attachment points may be positioned at same axial length alongthe longitudinal axis of the catheter 102 and/or may be positioned atdifferent axial lengths along the longitudinal axis of the catheter 102.

As shown in FIG. 10A, each pull wire 230 may diverge at an angle fromthe catheter 102 at a proximal end 104 or proximal portion of thecatheter 102 configured to be positioned outside of the body (e.g., nearor at the handle 206) and may be joined to a lever 232 or other control.The lever 232 may be pivotably joined to the handle 206 or to anattachment coupled to the handle 206 or to a proximal end 104 of thecatheter 102. The pull wire 230 may be joined to the lever 232 adistance away from the pivot point 238 such that the lever 232 acts as afulcrum. Adjusting the orientation of the lever 232 around the pivotpoint 238 may modulate the length of the pull wire 230 that divergesfrom the catheter 102 and correspondingly the length of the pull wire230 aligned along the catheter 102 to run parallel to the catheter 102,as the total length of the pull wire 230 will remain constant. Forexample, by pulling the lever 232 in a proximal direction, the length ofthe pull wire 230 that extends from the catheter 102 to the lever 232may be increased, thereby decreasing the length of the pull wire 230that runs parallel to the catheter 102. By shortening the length of thepull wire 230 that runs parallel to the catheter 102, the pull wire 230may cause the catheter 102 to effectively shorten its length along theside, which the pull wire 230 extends by bending the catheter 102 tocurve inward along the length of the pull wire 230. One or more levers232 may be connected to the handle 206. Each lever 232 may effectivelycontrol the length of one or more pull wires 230. Any suitable mechanismmay be used for modulating the effective length of the pull wire 230along the catheter 102. For example, in some embodiments, the proximalend of the pull wire 230 may be attached to a sliding mechanism thatslides, or is otherwise axially translatable, along an axial length ofthe handle 206 and/or catheter 102. In some embodiments, as illustratedin FIG. 10A, the control feature on the handle 206 used to control thepull wires 230 (e.g., the levers 232) may actuate within a plane that isparallel to the longitudinal axis of the handle 206. For example, asillustrated, the levers 232 pivot within a plane that is parallel to thelongitudinal axis of the handle 206.

A pull wire 230 may extend from a lever 232 or other control and becoupled to the length of the catheter 102 via a component such as thepull wire ring 234 depicted in FIG. 10B, or a similar mechanism. Thepull wire ring 234 may be a ring configured to be secured to the outercircumference of a proximal portion of the catheter 102 configured to bepositioned outside of the body. The pull wire ring 234 may include oneor more apertures 235 for introducing one or more pull wires 230 to thecatheter 102. An aperture 235 may position a distal portion of the pullwire 230 adjacent the catheter 102 so that the distal portion runsparallel to the catheter 102, such as by creating an access point wherethe pull wire meets, enters, and/or passes through the catheter 102. Asdescribed elsewhere herein, the pull wire 230 may run inside of thecatheter 102, outside of the catheter 102, or internally within asidewall 112 of the catheter 102 (e.g., the sidewall of the vacuum tube110). Portions of the catheter 102 may comprise one or more guides(e.g., rings, loops, notches, etc.) or other structures which allowaxial motion to the pull wire 230 relative to the catheter 102 butconfine the pull wire 230 to remain parallel to the catheter 102 along adistal length. The one or more apertures 235 may form guide paths whichdefine angles at which the pull wires 230 diverge away from the catheter102, for at least a portion of its length, as the pull wires 230 extendfrom the catheter 102 to the lever 232 or other control mechanism.

FIGS. 11A-11F schematically illustrate another example of a handle 208configured to manipulate pull wires 230. The handle 208 may include thesame or similar features as other handles described elsewhere herein.FIG. 11A depicts a perspective view of the handle 208. FIG. 11B depictsa top view of the handle 208. FIG. 11C depicts a top view of a crosssection of the handle 208. FIG. 11D depicts a side view of the handle208. The handle 208 may include a lever 233 for pulling or otherwisemanipulating one or more pull wires 230. FIG. 11E depicts a front viewof the lever 233. The lever 233 may comprise two halves configured to befixedly joined together around a circumference of portion of a shaft ofthe handle 208. The lever 233 may be pivotably joined to the handleshaft and create a fulcrum for modulating the length of the pull wire230 along the catheter 102, as described elsewhere herein. In someembodiments, the lever 233 may extend in one direction from the pivotpoint 238, similar to the embodiment illustrated in FIG. 10A. In someembodiments, the lever 233 pivots within a plane that is parallel to thelongitudinal axis of the handle 208.

In some embodiments, as illustrated in FIGS. 11A-11F, the lever 233 mayinclude two interconnected lever arms 233 a, 233 b positioned onopposite sides of the lever 233 (approximately 180 degrees from eachother around the circumference of the shaft) for controlling two pullwires 230. The pull wires 230 may extend along substantially oppositesides of the catheter 102 (approximately 180 degrees from each other).The lever 233 may include proximal attachment points 236 (e.g.,channels, or apertures) for attaching to the pull wires 230. The pullwires 230 may be fixedly secured to the proximal attachment points 236by any suitable means. In some embodiments, rotation of the lever 233around the pivot point 238 causes retraction of the pull wire 230 on oneside of the catheter 102 and allows extension of the pull wire 230 onthe opposite side of the lever 233, in some proportionate manner. Thetwo pull wires 230 may be attached to the lever 233 at the same or atdifferent distances from the pivot point 238. The distal ends of the twopull wires 230 may be fixed to the catheter 102 at the same or atdifferent axial points of the catheter 102. In some embodiments,rotating the lever 233 in one direction (e.g., clockwise) may cause asteerable portion of the catheter 102 to bend in a first direction,while rotating the lever 233 in the opposite direction (e.g.,counterclockwise) may cause a steerable portion of the catheter 102 tobend in a second direction, substantially opposite the first direction.Other arrangements of levers 233, including levers 233 attached to morethan two pull wires 230, are also possible.

As shown in FIG. 11C, the handle shaft may include one or more apertures235 for receiving a pull wire 230. The aperture 235 may position thepull wire 230 proximal to the catheter 102 (e.g., the vacuum tube 110)and the pull wire 230 may be introduced to the catheter 102 at aproximal end 104 of the catheter 102. The aperture 235 may introduce thepull wire 230 along a proximal portion of the catheter 102. In someembodiments, the catheter 102 may include an aperture through itssidewall 112 for allowing a pull wire 230 to extend into or through thesidewall of the catheter 102. In some embodiments, as seen in FIG. 11C,one or more of the fluid ports 222 of the handle 208 may vary indiameter (e.g., decrease) as the fluid port 222 lumen extends inwardtoward the catheter 102. The lumens may comprise step changes 223 indiameter, which may be configured to abut and properly seat a proximalend of the catheter 102 or one of the catheter 102 components (e.g., avacuum tube 110 or irrigation tube 130). In some embodiments, thevariable diameter of the fluid passage may facilitate forming afluid-tight seal with an inserted hose (e.g., a suction tube).

FIG. 11F schematically illustrates an example of a cross section of aportion of a handle 208 comprising two pull wires 230 coupled viasupport pins at proximal attachment points 236 to interconnected leverarms 233 a, 233 b. The pull wires may extend over, under, or into thevacuum tube 110, as described elsewhere herein. FIG. 11F illustrates anexample of a proximal end 104 of a catheter 102 as configured in FIGS.3A-3B. The vacuum tube 110 may be coupled to the irrigation tube 130 byan adhesive (e.g., a UV curable adhesive) applied between the outercircumference of the vacuum tube 110 and the inner circumference of theirrigation tube.

FIGS. 21A and 21B schematically illustrate another example of a handle212. FIG. 21A illustrates a side view of the handle 212 and FIG. 21Billustrates section A-A of handle 212 depicted in FIG. 21A. The handle212 may comprise the same or similar features as other handles describedelsewhere herein, particularly handle 208. The handle 212 may comprise alever 232 which comprises a generally circularly configuration. Thelever 232 may be centered so that a pivot point of the lever 232 ispositioned along a longitudinal axis of the handle 212 and/or catheter102. The lever 232 may be actuatable from either of two opposite sides,similar to the lever 232 of handle 208. Pull wires 230 may be coupled toproximal attachment points 236 (e.g., pins), as described elsewhereherein, which may be rotatable generally around a circumference of thecircular lever 232. The lever 232 may comprise a void space 240 throughwhich the pull wires extend from the catheter 102 to the proximalattachment points 236. The lever 232 may form a casing which surroundsand encloses the pull wires 230. The casing may protect the pull wires230 from the external environment. The lever 323 may comprise spacingelements such as rods 242, each of which may be configured to reorient apull wire 230 between the catheter 102 and the pull wire's proximalattachment point 236. The one or more spacing elements may prevent orinhibit the pull wire 230 from contacting (e.g., rubbing against)surfaces or edges of the lever 232 between the catheter 102 and theproximal attachment point 236 which may advantageously prevent damage tothe pull wire 232. The spacing elements may comprise smooth roundsurfaces, at least where the spacing elements contact a pull wire 230,in order to promote efficient translation of the pull wire 232 over thesurface of the spacing element when the lever 232 is actuated. In someembodiments, the lever 230 may comprise a central fulcrum or spacingelement across which one or more pull wires 230 may be translated (e.g.,slide). For instance, the lever 232 may comprise a cylindrical shapedspacing element located around the pivot point of the lever. In someembodiments, the spacing element may only correspond to a sector of acylinder. In some implementations, the spacing element may extend thedistance of the pull wire 230 path between the catheter 102 and theproximal attachment point 236. In some embodiments, one pull wire mayextend around the central spacing element to the opposite side of thelever 232. The two pull wires 230 may accordingly be coupled to the sameproximal attachment point 236 (one approaching from a distal side andone approaching from a proximal side) which may simply the manufacturingof the lever 232.

In some embodiments, the lever 233 may comprise only one lever arm 233 aextending from only one side of the handle. The finger port 228 may bepositioned opposite the lever arm 233 a on the opposite side of thehandle at approximately the same length along the longitudinal axis ofthe handle. Such a configuration may conveniently allow for a user tooperate both the pull wires 230 and suctioning (and/or irrigation) viathe finger port 228 with a single hand. In some implementations, thelever 233 may be laterally offset from the central longitudinal axis ofthe handle, such that the pull wire 230 that runs on the opposite sideof the lever 233 a may attach to the an attachment point 236 withoutinterfering with or obstructing the user's access to the finger port228.

FIG. 12 schematically illustrates another example of a handle 210. Thehandle 210 may include the same or similar features as other handlesdescribed elsewhere herein. In some embodiments, the handle 210 may beconfigured with more than two fluid ports 222 (e.g., three ports, fourports, five ports, etc.). FIG. 12 depicts a handle 210 comprising threefluid ports 222. Each fluid port 222 may be in fluid communication witha different lumen of the catheter 102 (e.g., the vacuum lumen 114 andtwo different irrigation lumens 134). In some embodiments, differentfluid ports 222 may be configured for introducing different ancillarydevices, such as an introducer, a guidewire, and/or a visualizationdevice.

In some embodiments, the irrigation lumen 134 or lumens may beconfigured to define an irrigation stream or streams of a specific size,shape, fluid velocity, and/or direction. The number, size, shape, and/orarrangement of irrigation lumens 134, for example, may influence theirrigation stream. The size, shape, velocity, and/or direction of theirrigation stream with respect to the one or more aspiration ports 116may be used to optimize the capture and removal of kidney stones orother debris. The shape and direction of an irrigation stream providedby an irrigation lumen 134 may be influenced or altered by a nozzle.

FIGS. 13A-13U schematically illustrate various examples of irrigationlumens and/or irrigation nozzles. An irrigation nozzle may be built-into the irrigation lumen 134 such that it is formed by a distal end ofthe irrigation lumen 134 opening into the irrigation port 136. Forexample, the shape of the distal portion of the irrigation lumen 134 mayform a nozzle 152. The irrigation nozzle 152 may, for example, be shapedas a cone having an expanding diameter as the lumen extends to meet theirrigation port 136, as shown in FIG. 13A. An irrigation nozzle 152 withan expanding diameter may increase the spread of the irrigation stream(the angle of the irrigation stream relative to the axis of theirrigation lumen 134) as the irrigation fluid exits the irrigation port136. The irrigation nozzle 152 may be shaped with a decreasing diameteras the irrigation lumen 134 extends to the irrigation port 136, as shownin FIG. 13B. The irrigation stream may at least partially converge as itexits the irrigation port 136. The irrigation nozzle 152 may be shapedwith a constant diameter. The irrigation nozzle 152 may reduce thecross-sectional area of the irrigation port 136 and may create multipleirrigation ports 136. For example, the nozzle may comprise a wallpositioned at a distal end of the irrigation lumen 134 having a numberof apertures forming a number irrigation ports 136, as shown in FIG.13C. The irrigation lumen 134 may change directions along a distalportion of the lumen extending to the irrigation port 136. For example,the irrigation lumen 134 may be angled to extend radially outward fromthe longitudinal axis of the catheter 102, as shown in FIG. 13D. Theirrigation lumen 134 may be angled to extend radially inward from thelongitudinal axis of the catheter 102, as shown in FIG. 13E. Angling ofthe irrigation lumen 134 adjacent the irrigation port 136 may alter thedirection of the irrigation stream, particularly with respect to thesuction stream extending into the aspiration port 116. The irrigationnozzle 152 may be configured to align the irrigation streamsubstantially parallel to the suction stream, away from the suctionstream, or toward the suction stream. The irrigation stream may beconfigured to extend from the irrigation port 136 as a substantiallyuniform stream, as depicted in FIG. 13F, experiencing little divergencein the spread or span of the stream directly adjacent to the irrigationport 136. The irrigation stream may be configured to extend as asubstantially conical irrigation stream, as depicted in FIG. 13G,experiencing immediate divergence in the spread or span of the streamdirectly adjacent to the irrigation port 136.

In some embodiments, the irrigation stream may be shaped by the nozzle152 and/or irrigation port 136. For example, the irrigation stream maybe relatively oblong or flat, having a first dimension substantiallylonger than a second dimension (e.g., a dimension transverse to thefirst dimension). FIG. 13H depicts the distal face of a catheter 102comprising an oblong irrigation port 136. The irrigation stream may befanned (e.g., flat with a divergent dimension). The flat irrigationstream may diverge along the shorter direction, the longer direction, orboth. The flat irrigation stream may be oriented in any direction withrespect to the catheter 102 (e.g., horizontally, vertically, diagonally,etc.) The irrigation stream may be annular (e.g., ring shaped). Theirrigation stream may be emitted in any shape (e.g., circular,triangular square, arced, etc.) and configured to converge, diverge, orextend substantially parallel to the irrigation port 136 as it isemitted from the irrigation lumen 134. FIG. 13I depicts another exampleof a catheter 102 configured to produce a flat irrigation stream via aplurality of linearly arranged irrigation ports 136. The size of theirrigation port 136 and/or the spacing of a plurality of adjacentirrigation ports 136 may also influence the resulting irrigation stream.In some embodiments, a plurality of adjacent irrigation ports 136 may beformed at the end of one or more irrigation lumens 134, such as by anozzle 152 (e.g., an irrigation lumen 134 comprising multiple irrigationports 136). In some embodiments, a plurality of adjacent irrigationports 136 may be formed from a plurality of adjacent irrigation lumens(e.g., each irrigation port 136 is in fluid connection with a differentirrigation lumen 134). For a given applied fluid pressure, the size ofthe irrigation port 136 (e.g., the cross-sectional area or diameter) mayaffect the fluid velocity of the irrigation stream as it exits theirrigation port 136. Smaller openings can be used to generate high fluidvelocities and larger openings can be used to generate lower fluidvelocities. Similarly, the cumulative cross-sectional area of theirrigation ports 136 for a given irrigation lumen 134 may be used tomodulate the fluid velocity through the irrigation ports 136. The totalnumber of irrigation ports 136 per irrigation lumen 134 may affect thecumulative cross-sectional area. For example, FIG. 13J depicts a distalface of a catheter 102 comprising a plurality of closely positionedirrigation ports 136, while FIG. 13K depicts a distal face of a catheter102 comprising a larger plurality of closely positioned irrigation portsspanning a larger area than that of FIG. 13J. In some implementations,the same number of irrigation lumens 134 (e.g., one irrigation lumen)may join the irrigation ports 136 in FIGS. 13J and 13K to pressurizedfluid sources. The irrigation stream or streams in FIG. 13J may havehigher fluid velocity than the irrigation stream or streams in FIG. 13K.The irrigation stream in FIG. 13J may be more jet-like than theirrigation stream in FIG. 13K, which may be more shower-like.

The arrangement (e.g., proximity) of adjacent irrigation ports 136 mayalso affect the irrigation stream. FIG. 13L depicts the distal face of acatheter 102 having the same number of similarly sized irrigation portsas in FIG. 13J, but spaced further apart. In some implementations, theirrigation streams from the irrigation ports 136 in FIG. 13J may be morelikely to converge into a single jet stream than the further spacedirrigation streams emanating from the irrigation ports 136 in FIG. 13L.FIG. 13M depicts the distal face of a catheter 102 comprising a singleirrigation port 136 having a larger cross-sectional area than theirrigation ports 136 depicted in FIGS. 13I-13L. The largercross-sectional area of the irrigation port 136 may result in anirrigation stream with a heavier flow mass (a higher volumetric flowrate). The heavier flow mass may be particularly advantageous in moving(e.g., dislodging) kidney stones. FIG. 13N depicts an example of anozzle 152 comprising a rotatable ball 135 positioned within the nozzle152. The rotatable ball 135 may cause a swirling or vortex effect on theirrigation stream as pressurized irrigation fluid is applied and forcedto move across the rotatable ball 135 to reach the irrigation port 136.The fluid velocity may also affect the tendency of the irrigation streamto vortex. In general, larger fluid velocities may more readily create avortex effect in the irrigation stream. In some embodiments, largerfluid velocities may be promoted by using smaller syringes (e.g., 10cc). The nozzle may include any other conventional feature, such asthose used on garden hoses, for creating a variety of irrigation streamfeatures or patterns. In some embodiments, the diameter of an irrigationport 136 may be about 0.001 inches, 0.025 inches, 0.005 inches, 0.0075inches, 0.01 inches, 0.02 inches, 0.03 inches, 0.04 inches, 0.05 inches,0.06 inches, 0.07 inches, 0.08 inches, 0.09 inches, 0.1 inches, lessthan 0.0001 inches, more than 0.1 inches, or a diameter selected fromany range defined there between. In some embodiments, two or moreirrigation ports 136 may be spaced apart (e.g., from center-to-center)by about 0.001 inches, 0.025 inches, 0.005 inches, 0.0075 inches, 0.01inches, 0.02 inches, 0.03 inches, 0.04 inches, 0.05 inches, less than0.001 inches, more than 0.005 inches, or any length from a range definedthere between.

The nozzle 152 may be configured to direct the irrigation stream from alateral irrigation port 136, such as in a lateral direction, somewhatproximal direction, or somewhat distal direction, as shown in FIG. 13O.In some embodiments, the nozzle may direct the irrigation stream in alateral direction that is not normal to the surface of the catheter,such as toward a circumferentially adjacent aspiration port 116.

An irrigation nozzle 150 may be formed externally to the irrigation port136. In some embodiments, the nozzle 150 may be a flange that directsthe irrigation flow in a certain direction (e.g., toward or away fromthe suction stream), as depicted in FIG. 13P. In some embodiments, thenozzle 150 may surround the irrigation port 136 and may comprise adecreasing diameter as it extends distally, as depicted in FIG. 13Q. Insome embodiments, the nozzle 150 may surround the irrigation port andmay comprise an increasing diameter, as depicted in FIG. 13R. In someembodiments, the nozzle 150 may be formed around the distal end of thecatheter 102. For example, as described elsewhere herein, an irrigationtube 130 may extend concentrically around a vacuum tube 110 forming oneor more irrigation ports 136 between the outer diameter of the vacuumtube 110 and the inner diameter of the irrigation tube 130, as shown inFIG. 3A and as depicted in FIG. 13S. The portion of the irrigation tube130 that extends distally of the vacuum tube 110 may form a nozzle 150.The nozzle 150 may alter the shape and/or direction of the irrigationstream or streams provided from the one or more irrigation ports 136. Insome embodiments, the nozzle 150 may have an increasing diameter, asdepicted in FIG. 13T. In some embodiments, nozzles may be formedadjacent lateral irrigation ports, as depicted in FIG. 13U.

In some embodiments, the irrigation nozzle 150 may be formed from anirrigation tube 130 that is positioned concentrically around a vacuumtube 110, as shown in FIGS. 3A-3B, but in which the distal end of theirrigation tube 130 is positioned proximally behind the distal end ofthe vacuum tube 110. The inner diameter of irrigation tube 130 may beadhered to the outer diameter of the vacuum tube 110 around a portion ofthe circumference of the vacuum tube 110 such that the resultingirrigation port 136 formed between the vacuum tube 110 and theirrigation tube 130 is not annular, but only extends around a portion ofthe circumference of the catheter 102. For instance, a distal portion ofthe irrigation tube 130 may be heat melted to the vacuum tube 110forming a fluid seal there between. FIG. 13V schematically illustrates adistal end view of a catheter 102 comprising a vacuum tube 110 and aconcentric irrigation tube 130 which is sealed around a portion of itscircumference to the vacuum tube 110. The adherence of the irrigationtube 130 to the vacuum tube 110 may form a more continuous taper orsmoother transition between the outer diameter of the vacuum tube 110and the outer diameter of the irrigation tube 130 at the distal end ofthe catheter 102. The taper may be advantageous for advancing ortracking the catheter 102 through an access sheath, the urethra, ureter,and/or other anatomical lumen and may help prevent the irrigation tube130 from being forced proximally backward from the distal end of thevacuum tube 110. The seal between the irrigation tube 130 and the vacuumtube 110 may prevent the distal end of the irrigation tube 130 frombeing displaced relative to the distal end of the vacuum tube 110.

The formation of a fluid seal between the irrigation tube 130 and thevacuum tube 110 around a portion of the circumference of the catheter102 may form a nozzle 150 which alters the irrigation stream. Theirrigation port 136 formed in such an embodiment may be formed over aradial sector of the catheter 102 of approximately 270 degrees, 180degrees, 90 degrees, 60 degrees, 50 degrees, 40 degrees, 30 degrees, 20degrees 10 degrees, more than 270 degrees, less than 10 degrees, or someangle defined in a range there between. In some implementations, thesealing of the irrigation tube 130 to the vacuum tube 110 around aportion of the circumference may form a nozzle 150 which alters theirrigation stream. The nozzle 150 may have altered dimensions relativeto the remainder of the irrigation tube 110 resulting from the sealing.For example, the nozzle 150 may have a slightly expanded outer diameterresulting from the excess material accumulating along the nozzle 150when the irrigation tube 130 is drawn radially inward toward the vacuumtube 110 to be sealed. In some embodiments, a lateral hole 137 may beformed along a distal edge of the irrigation tube 110 to help shape thenozzle. The lateral hole 137 may be formed by cutting back a distal edgeof the irrigation tube 110. A portion of the edges of the hole may besealed to the irrigation tube 110 as schematically depicted in FIG. 13W,leaving the remaining portion of the hole to form the irrigation lumen136. The incorporation of the nozzle 150 from partially sealing theirrigation tube 130 to the vacuum tube 110 may increase the fluidvelocity of the irrigation stream for a constant applied volumetric flowrate. The nozzle 150 may result in a more focused, jet-like irrigationstream than the irrigation stream emitted from an unsealed irrigationtube 110. For instance, the irrigation stream may have less of atransverse spread than in an unsealed embodiment. The use of the nozzle150 as described in relation to FIGS. 13V and 13W may allow moredirected irrigation. In some embodiments, the irrigation stream may bedirected in a distal direction and, in other embodiments, the irrigationstream may be directed in an off-angled direction. In someimplementations, the catheter 102 may be rotated by the user to alterthe relative positioning of the irrigation stream relative to theaspiration port 116. A marking, or other fiduciary feature, such as apull wire lever as described elsewhere herein, may be used to track thecircumferential positioning of the irrigation port 136. Rapid rotationof the catheter 102 may create a fluid swirling effect. In someembodiments, the nozzle 150 may create a relatively flatter jet stream.The shape of the lateral hole 137 may be used to alter the resultingirrigation stream.

The arrangement of the one or more irrigation streams with respect tothe one or more aspiration ports 116 may be configured to optimizeremoval of kidney stones or other debris. FIGS. 14A-14C schematicallydepict various examples of the direction of irrigation streams relativeto the suction stream. In some embodiments, the one or more irrigationstreams may be configured to extend in a direction substantiallyparallel to the longitudinal axis of the catheter 102. Depending on thepositioning of the one or more aspiration ports 116, the irrigationstreams may extend in a direction substantially parallel to a suctionstream as well, as depicted in FIG. 14A. The irrigation stream orstreams may be arranged concentrically surrounding or partiallysurrounding an aspiration port 116. For example, an irrigation lumen 134may be formed by an irrigation tube 130 positioned around the outercircumference of a vacuum tube 110, as depicted in FIGS. 3A-3B or one ormore irrigation lumens 134 may be formed in a sidewall of the vacuumtube 110, as depicted in FIG. 5E or FIG. 5F. In some embodiments, theone or more irrigation streams may be configured to extend radiallyoutward away from the longitudinal axis of the catheter 102. Theirrigation stream or streams may form an irrigation cone surrounding theaspiration port 116, in which irrigation fluid is expelled distally andradially outward around the aspiration port 116, as depicted in FIG.14B. In some embodiments, the irrigation stream or streams may form anirrigation cone surrounding the aspiration port 116, in which irrigationfluid is expelled distally and radially inward around the aspirationport 116, such that the direction of the irrigation stream or streamsintersects the longitudinal axis of the catheter 102, as depicted inFIG. 14C.

FIGS. 15A-15F schematically illustrate various examples of catheterscomprising different arrangements of suction and irrigation. In someembodiments, an irrigation port 136 may be provided along the length ofthe catheter 102 at a position distally of an aspiration port 116, asshown in FIG. 15A. The irrigation stream may help direct kidney stonestoward the aspiration port 116. The aspiration port 116 may be formed ina sidewall of the catheter 102 as a lateral port. In some embodiments,the aspiration port 116 may face a distal direction and the irrigationlumen 134 may extend distally beyond the aspiration port 116, asdepicted in FIG. 15B. For example, the irrigation lumen 134 may extendthrough the aspiration lumen and beyond the aspiration port 116. Theirrigation port 136 may face a distal direction (aligned along thelongitudinal axis of the catheter 102). A distal portion of theirrigation lumen 134 beyond the aspiration port 116 may be curved suchthat the irrigation stream is directed in a direction offset from thedistal direction. For example, the irrigation stream may be directedalong an angle relative to the longitudinal axis less than 45 degrees,45 degrees, 90 degrees, 135 degrees, 180 degrees, 225 degrees, more than225 degrees, or any angle in ranges there between. FIG. 15B depicts anirrigation tube 130 bent between 90 degrees and 180 degrees (about 235degrees) to direct irrigation fluid in a proximal and lateral direction.FIG. 15C depicts an irrigation tube 130 bent 180 degrees to directirrigation fluid in a proximal direction. In some embodiments, as shownin FIG. 15C, irrigation fluid may be directly straight toward anaspiration port 116. As described elsewhere herein, directing irrigationfluid into or toward an aspiration port can increase the effectivepressure difference across the irrigation port 136 and facilitatesuctioning of kidney stones or other debris. In some implementations,the irrigation may be optimized such that suctioning can be eliminatedor not used altogether, or at least such that the amount of negativepressure applied to the vacuum lumen 114 can be reduced. The curveddistal portion of the irrigation lumen 134 may be formed such that thecurve is a permanent part of the shape of the catheter 102. In someembodiments, the distal portion may be steerable, as described elsewhereherein, and the curved portion may be implemented by steering the distalend to assume the curved shape described herein. In some embodiments,the distal portion may be steerable and formed such that it is biased toassume the curved shape, such as when no force is applied. The shape ofthe curve may be altered (e.g., the angle of the distal end relative tothe longitudinal axis may be increased or decreased), such as bymanipulation of pull wires 230, as described elsewhere herein, or by anyother suitable means. For example, the curved distal portion may bestraightened or even curved in an opposite direction (e.g., away fromthe aspiration port 116). Providing irrigation in the direction of theaspiration port 116 (e.g., by curving the distal end having theirrigation port 136 toward the aspiration port 116) may advantageouslyincrease the suction pressure experienced at the aspiration port 116,which may facilitate the removal of kidney stones. Additionally oralternatively, the irrigation tube 130 may include a lateral irrigationport 136. The irrigation port 136 may be positioned on the side of theirrigation tube 130 facing toward the path of suction leading into theaspiration port 116. In some embodiments, the distal end 106 of thecatheter 102 or the distal end of an irrigation tube 130 may be curvedtoward a proximal direction so as to face at least partially toward alateral aspiration port 116, as depicted in FIG. 15D. In someembodiments, the catheter 102 may include both distal-facing andlateral-facing aspiration ports 116. FIGS. 15E and 15F depict aperspective view and cross section, respectively, of an example of acatheter 102 comprising a distal-facing aspiration port 116 and alateral-facing aspiration port 116 in addition to a distally facingirrigation port 136. In some embodiments, the irrigation port 136 may bepositioned on a substantially opposite side of the catheter 102 as thelateral-facing aspiration port 116 (approximately 180 degreescircumferentially offset).

The shape of the one or more irrigation streams ejected from the one ormore irrigation ports 136 may also depend on other hydrodynamicproperties, including the flow rate or pressure of the irrigation fluid,the viscosity of the irrigation fluid, the pressure of the externalenvironment, the viscosity of fluid within the external environment,etc. In some embodiments, irrigation may be provided at a flow rate ofabout 1, 5, 10, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 200,300, 500, less than 1, or greater than 500 ml/min, or a flow rateselected from a range there between. In some embodiments, negativepressure may be applied to provide suction or positive pressure may beapplied to drive irrigation at a pressure of about 5, 10, 20, 25, 30,40, 50, 60, 70, 80, 90, 100, 125, 150, 200, 300, 500, 1000, 2000, 5000,less than 1, or greater than 5000 mmHg, or a pressure selected from arange there between. In some implementations, the vacuum may bemaintained below a maximum pressure (e.g., 150 mmHg) for safety reasons.The irrigation stream may be configured to provide laminar flow orturbulent flow for a particular application (e.g., use within the ureteror kidney). The dimensions of the irrigation lumen 134 and nozzle aswell as the amount of pressure applied to the irrigation fluid may beused to configure the type of fluid flow from the irrigation port 136.The pressure applied to the irrigation fluid may be dynamic, even duringperiods when irrigation fluid is continuously delivered. For example,the pressure may be oscillated (e.g., via a sinusoidal waveform)providing a pulsed pressure effect. The shape, spread, flow rate, and/ortype of flow of the irrigation stream may oscillate or otherwise varyalong with the differential pressure applied to the irrigation fluid.The catheter 102 may be configured to expel pulses of irrigation fluidor higher pressurized pulses of irrigation fluid at a certain frequency(e.g., less than 0.1 Hz, 1 Hz, 10 Hz, 50 Hz, 100 Hz, more than 100 Hz,etc., or a frequency selected from a range there between). The dynamicirrigation stream may be configured to optimize removal of kidneystones. The positive pressure source which pressurizes the irrigationfluid may be coupled to and controlled by a controller. The controllermay have means for adjusting the parameters of the irrigation, such asthe frequency of pulsing and/or pressure of pulsing. In someimplementations, the levels of suctioning and irrigation may be matchedto provide constant pressure or volumetric flow within the physiologicallumen or cavity (e.g., the kidney). For instance, the matching maymaintain a substantially constant level of irrigation fluid within aspace such as a calyx. In some implementations, irrigation may providemore pressure or volumetric flow than suctioning. In someimplementations, irrigation may provide less pressure or volumetric flowthan suctioning. Over-pressurization may be prevented such as by fingerport 228 as described elsewhere herein which may equilibrate thepressure with the ambient atmosphere. Too little irrigation may notdislodge a kidney stone and/or may not prevent suctioning of adjacenttissue. Too much irrigation, particularly relative to the amount ofsuction, may dislocate the kidney stone away from the catheter 102before it is caught up in the suctioning of the catheter 102.

In some embodiments, the catheter 102 may comprise more than oneirrigation lumen 134, as described elsewhere herein. In embodiments,comprising a plurality of irrigation lumens 134, each lumen may beconnected to the same or to different sources of positive pressure. Inembodiments where a plurality of pressure sources are connected to aplurality of irrigation lumens 134, the same pressure profile may beapplied to each lumen or the irrigation through each lumen may beseparately controlled according to different pressure profiles. In someembodiments, the irrigation flow through a plurality of irrigationlumens 134 may be configured to create a particular flow pattern at thedistal end of the catheter 102. Pressurized irrigation fluid may beprovided to the plurality of irrigation lumens 134 such that irrigationfluid is expelled at different times, for different durations, and/or atdifferent pressures and flow rates from the plurality of irrigationports 136. For example, the catheter 102 may comprise a plurality ofirrigation ports 136 positioned around a circumference of the distal end106 of the catheter 102 (e.g., around an aspiration port 116) andirrigation fluid may be expelled from the plurality of irrigation ports136 in a sequential pattern travelling clockwise or counterclockwise.The period of positive flow from each irrigation port 136 may overlapwith an adjacent irrigation port 136 or may not overlap. In someembodiments, irrigation fluid may be continuously expelled from eachirrigation port 136 over a period of time, but a wave of highpressurization may travel along the circumference of the distal end ofthe catheter 102, alternatively applying a pulse of high pressure to oneor more of the plurality of irrigation ports 136. A number ofcombinations and various patterns are possible. In some embodiments, thecontroller may comprise a number of pre-set programs for applyingparticular pressure profiles or irrigation sequences to the catheter 102that a user may select from for the procedure. Providing dynamicirrigation, in terms of the spatial and/or temporal distribution of theirrigation flow from a stationary catheter, may create flow patternsthat are configured to dislodge debris, such as kidney stones fromphysiological tissue.

Various combinations and patterns of aspiration (suction) and irrigationmay be applied by the catheter 102 during a procedure, such as aprocedure to remove kidney stones from the kidney, ureter, or otherportion of the urinary tract. In some embodiments, both suction andirrigation may be provided continuously. In some embodiments, suctionmay be provided continuously and irrigation may be providedintermittently. In some embodiments, irrigation may be providedcontinuously and suction may be provided intermittently. In someembodiments, both suction and irrigation may be provided intermittently.In embodiments where suction and/or irrigation is providedintermittently, the intermittent application of suction and/orirrigation may be provided automatically based on a predeterminedprofile or may be provided manually by the spontaneous control of a user(e.g., during a period for which the user actuates a control, such as abutton or finger port 228 on the handle 200 of the catheter 102). Insome embodiments, the user may use a control to transiently override apredetermined profile. In some embodiments, the irrigation and/oraspiration, as well as any other function that may be included in theremoval device 100, can be controlled by a controller. The controllermay include memory and/or a processor. The controller may store programsor algorithms for operating irrigation and/or aspiration of the removaldevice 100. The controller may be an integral part of the device (e.g.,part of the handle 200) or may be a stand-alone device. The stand-alonedevice may be connected to the vacuum source and pressurized fluidsource electronically (e.g., through one or more cables or wirelessly)or may be part integral with the vacuum source and pressurized fluidsource. The vacuum source and pressurized fluid source may be connectedto the handle 200 through one or more vacuum tubes and one or moreirrigation lines. The tubes and lines may be combined into singlecables. In some embodiments, the controller may be intermediatelypositioned along the vacuum tubes and irrigation lines, such that theyrun through the controller. The controller may include and/or controlpumps and/or valves, which it uses to create or modulate the pressure ofaspiration and irrigation applied to the removal device 100 and/or toselectively apply pressure to various tubes or lines. The controller mayinclude an interface for receiving input or commands from a user (e.g.,buttons, dials, sliders, keyboards, a mouse, a stylus, touchscreens,etc.). A user may set values of aspiration pressure and/or irrigationpressure or flow rate via the controller. The values may be incrementalor continuous (e.g., analog). In some embodiments, the user may be ableto select which vacuum lumen 114 and/or irrigation lumen 134 isactivated (provided pressure). In some embodiments, the removal devicemay be operatively connected to a computer, laptop, tablet, which mayserve as the controller. The device may include a display (e.g., adisplay screen or a digital numerical indicator). A collection containermay be placed downstream of the vacuum lumen 114 for collecting debris.In some embodiments, the device may include a safety shut-off feature,such as an automatic pressure release valve, if a measure pressure (suchas in the vacuum lumen 114) exceeds a predetermined threshold.

In some embodiments, intermittent suction may be provided simultaneouslywith intermittent irrigation. In some embodiments, intermittent suctionand intermittent irrigation may be provided alternatively to oneanother. That is, suction may be provided during any period in whichirrigation is not provided and irrigation may be provided during anyperiod in which suction is not provided. For example, in someimplementations, irrigation may be provided as a default, except duringa period when suction is positively activated by a user in which caseirrigation is temporarily stopped. In other implementations, suction maybe provided as a default, except during a period when irrigation ispositively activated by a user in which case suction is temporarilystopped. In some embodiments, periods of suction and irrigation mayoverlap partially but not entirely. In some embodiments, periods ofsuction and/or irrigation may be repeated at a regular interval. Theperiods of suction and/or irrigation may endure about 0.1 s, 1 s, 5 s,10 s, 15 s, 20 s, 30 s, 45 s, 60 s, less than 0.1 s, more 60 s, or aduration in any range there between. The periods of rest (no suctionand/or no irrigation) may be about 0.1 s, 1 s, 5 s, 10 s, 15 s, 20 s, 30s, 45 s, 60 s, less than 0.1 s, more 60 s, or a duration in any rangethere between. In some embodiments, the periods of suction may be about1×, 1.25×, 1.5×, 1.75×, 2×, 3×, 5×, 10×, 50×, 100×, less than 1×, morethan 100×, or a multiple in any range there between longer than theperiod of irrigation. In some embodiments, the periods of irrigation maybe about 1×, 1.25×, 1.5×, 1.75×, 2×, 3×, 5×, 10×, 50×, 100×, less than1×, more than 100×, or a multiple in any range there between longer thanthe period of suction. There may be 1, 2, 3, 4, 5, 10, 20, 30, 50, 100,more than 100 pulses of irrigation, or a number in any range therebetween, for each pulse of suction. There may be 1, 2, 3, 4, 5, 10, 20,30, 50, 100, more than 100 pulses of suction, or a number in any rangethere between, for each pulse of irrigation.

As described elsewhere herein, pulsatile irrigation and/or pulsatilesuctioning may be provided as continuous or stepped reductions/increasesin irrigation or suction pressure (e.g., comprising a sine wave profileor any other suitable profile), may be provided as switching pressure onand off altogether (e.g., a square wave profile or any other suitableprofile), or may be provided as any combination thereof. Pulsatileirrigation and pulsatile suctioning (aspiration) may be providedseparately, simultaneously, or only one of irrigation and suctioning maybe pulsed. When provided together, pulsatile irrigation and pulsatilesuctioning may be synchronized. For example, suctioning may increase asirrigation decreases and vice versa. Alternatively, suctioning andirrigation may increase and decrease together. Pulsatile irrigation andpulsatile suctioning may be provided at the same or differentfrequencies. The removal device 100 may be configured to providecombinations of pulsatile, continuous, and/or on-demand suctioningand/or irrigation. In some implementations, kidney stone removal may beoptimized by effectively placing the kidney stones in suspension withinthe kidney. Kidney stone removal may further be optimized by effectivelyfluidizing the suspended kidney stones. Breaking the kidney stone intosmaller sized kidney stones may facilitate suspending and/or fluidizingthe kidney stones. In some implementations, providing high frequencysuctioning and/or high frequency irrigation may optimize kidney stoneremoval. Frequencies above, for example, about 1 Hz, 10 Hz, 50 Hz, 100Hz, 500 Hz, 1 kHz, or more than 1 kHz may be considered high frequencypulsing. High frequency pulsing of suctioning and/or irrigation may helpplace kidney stones in suspension and/or may help fluidize the kidneystones such that they are more readily removed via the removal device100.

In some implementations, it may be most effective to systematically loadand unload a calyx containing stones with irrigation fluid. In otherwords, the calyx may be substantially filled with irrigation fluid andthen suction may be initiated to aspirate the volume of irrigation fluidfrom the calyx. Irrigation may be halted during suctioning or the rateof irrigation may be slower than the rate of suctioning such that thereis a net decrease in the volume of the irrigation fluid. In otherembodiments, the rate of irrigation may be substantially equal to therate of suctioning, in which case suctioning may not decrease the netvolume of irrigation fluid within a space, but the volume maynonetheless be gradually replaced with fresh irrigation fluid. Sometests have shown that stones are more efficiently removed from thekidney using relatively longer durations of suctioning and/or lessfrequent applications of suctioning. For example, the suctioning may beat least 1 s, 2 s, 3 s, 4 s, 5 s, 6 s, 7 s, 8 s, 9 s, 10 s, 11 s, 12 s,13 s, 14 s, 15 s, 20 s, 25 s, 30 s, or more than 30 s long. Similarly,periods of irrigation without suctioning may be at least 1 s, 2 s, 3 s,4 s, 5 s, 6 s, 7 s, 8 s, 9 s, 10 s, 11 s, 12 s, 13 s, 14 s, 15 s, 20 s,25 s, 30 s, or more than 30 s long. The application of suctioning to thevolume of irrigation fluid may facilitate fluidizing the stones withinthe irrigation fluid. For instance, application of suctioning may impartmomentum to the stones which makes them easier to remove. Pulses ofaspiration less than a threshold duration may cease before the stonesare optimally fluidized, hampering the removal of stones, yet, maydecrease the total irrigation volume, making subsequent fluidizationmore difficult. Periods of irrigation without suctioning may serve tofill or refill a calyx or other space with irrigation fluid. Periods ofnet positive irrigation less than a threshold value may not adequatelyfill the space and may lead to sub-optimal fluidization of the stoneswithin the space during subsequent periods of aspiration. Maintaining aminimum level of irrigation volume within a space during aspiration maydecrease the chances of tissue damage from the suctioning as describedelsewhere herein. Some embodiments include a period of irrigation inwhich from 1 cc to 20 cc, from 5 cc to 15 cc, from 8 cc to 12 cc, orabout 10 cc of irrigation fluid is infused into a calyx followed bysustained aspiration lasting from 0.2 s to 10 s, from 0.5 s to 5 s, from0.8 s to 3 s, or from 1 to 2 s. In such embodiments, irrigation fluidmay continue to be infused during the aspiration period, or may bediscontinued during the aspiration period.

In some implementations, a stone collection canister, as describedelsewhere herein, or other fluid trap connected downstream of theaspiration lumen may be used to monitor user cycling of aspiration. Forexample, the fluid trap may hold a certain of volume of fluid (e.g., viagravity) before the fluid rises to an exit port and continues to flowalong the aspiration pathway. The user may visually monitor the volumelevel of the fluid trap. One or more volume levels could bequantitatively or qualitatively (e.g., full, half-full, etc.) indicatedon the fluid trap through markings (e.g., hash-marks) or other suitablemeans. The volumes within the fluid trap could be calibrated to theparticular application, such as to the volume of a renal calyx. When thecollected volume rises to a certain level, the volume could serve as anindicator to the user to halt the suctioning (e.g., by covering a fingerport 228) and/or to reinitiate irrigation. In some embodiments, theindicator volume may be a volume at which the collected fluid rises tothe exit port and begins flowing through an upstream aspiration line. Insome implementations, the user may halt suctioning and/or initiateirrigation when fluid is observed to stop flowing through the aspirationline, indicating the body space (e.g., the calyx) is substantially empty(or that the vacuum lumen 114 is clogged). One or more cycles ofaspiration may be performed within each target space, as describedelsewhere herein. In some embodiments, a fluid syringe used forsupplying irrigation fluid, such as a SAPS™ syringe, may automaticallyrefill upon release of the syringe, facilitating successive flushing ofthe calyx or other body space. In some implementations, the time ittakes to empty and/or refill a syringe may be used to calibrate theduration of the aspiration and/or irrigation pulses.

Disclosed herein are also various methods for using a removal devicecomprising aspiration and irrigation to remove kidney stones from thekidney, ureter, or other portion of the urinary tract. The methodsdescribed herein may be performed with embodiments of the removal device100 and systems described herein or any other suitable device. Theremoval device 100 comprising aspiration and irrigation can be insertedthrough the urethra to a point along the urinary tract proximate to oneor more kidney stones. The removal device 100 may be inserted proximallyof the one or more kidney stones or the device may be inserted distallyof the one or more kidney stones. In some embodiments, the removaldevice 100 is advanced in a distal direction toward and/or past theplurality of kidney stones while applying aspiration and/or irrigation.For example, the removal device 100 may be advanced from the renalpelvis, into a major calyx of the kidney, and further into a minor calyxof the kidney, or along any portion of such a path. In someimplementations, the removal device 100 may provide aspiration and/orirrigation according to one of the patterns or profiles describedelsewhere herein during the advancement of the removal device 100. Insome embodiments, the removal device 100 is retracted in a proximaldirection past and/or away from the plurality of kidney stones whileapplying aspiration and/or irrigation. For example, the removal device100 may be retracted from a minor calyx of the kidney, into a majorcalyx of the kidney, and further into the renal pelvis, or along anyportion of such a path. The removal device 100 may provide aspirationand/or irrigation according to one of the patterns or profiles describedelsewhere herein during the retraction of the removal device 100. Insome embodiments, the removal device 100 may be reciprocated along aproximal-to-distal direction. For example, the removal device 100 may bemoved back and forth along trajectory between the renal pelvis and aminor calyx or along a smaller trajectory defined therein or along alarger trajectory encompassing such a path. The removal device 100 maybe reciprocated back-and-forth for any number of suitable cycles (e.g.,1 cycle, 2 cycles, 3 cycles, 4 cycles, 5 cycles, 10 cycles, 20 cycles,50 cycles, 100 cycles, more than 100 cycles, or any number cycles in arange there between, etc.). The removal device 100 may be reciprocatedat a substantially constant frequency.

In some implementations, the removal device 100 is manually translocatedin a distal and/or proximal direction by the user manually moving aproximal portion of the removal device 100 outside of the body (e.g.,handle 200) in a proximal and/or distal direction. In someimplementations, the removal device 100 comprises an internal componentand an external component surrounding the internal component. Theinternal component and/or the external component may be independentlyadvanceable with respect to the other for at least some separabledistance. For example, the internal component may be a vacuum tube 110and the external component may be a concentric irrigation tube 130. Thevacuum tube 110 may be able to be advanced distally and retractedproximally while the irrigation tube 130 remains stationary and/or theirrigation tube 130 may be able to be advanced distally and retractedproximally while the vacuum tube 110 remains stationary. In someembodiments, the internal component and the external component may beseparable such that the distal end of the internal component may bepositioned either distally to or proximally to the distal end of theexternal component. In some embodiments, the internal component and theexternal component may be separable such that the distal end of theinternal component is always distal to (or at least aligned with) thedistal of the external component or the distal end of the externalcomponent is always distal to (or at least aligned with) the distal endof the internal component. In some embodiments, a catheter 102comprising the vacuum tube 110 and one or more irrigation lumens 134 maybe the internal component and an external sheath may be the externalcomponent. Use of an external sheath may prevent pain, discomfort, orirritation along a length of the urinary tract by allowing the internalcomponent to move back and forth freely while providing a stationarybarrier between the internal component and the urinary tract over alarge portion of the length of the catheter 102.

In some embodiments, the internal component or the external componentmay be proximally and distally translatable using a mechanism providedon a handle 200 configured to be positioned outside the body of thepatient. For example, the handle 200 may comprise a lever or a slidingknob which is coupled to the internal component. The user may distallyadvance or proximally retract the internal component by actuating themechanism. The mechanism may limit the amount of separation achievablebetween the internal component and the external component. In someembodiments, an irrigation port 136 (e.g., irrigation tube 130) may beproximally retracted during suction. Retracting the irrigation port 136may dissipate the displacement force of the irrigation stream afterdislodging a kidney stone and allow the aspiration port 116 to bettercapture the kidney stone. In some embodiments, the irrigation port 136is advanced distally during aspiration. Advancing the irrigation port136 may increase irrigation pressure to facilitate dislodging a kidneystone. The irrigation pressure may be adjusted as needed by axiallytranslocating the irrigation port 136. In some embodiments, theaspiration port 116 (e.g., vacuum tube 110) is axially translocated toinduced the same effects. In some embodiments, an aspiration port 116and an irrigation port 136 are axially moved relative to one another,simultaneously and/or sequentially.

FIGS. 16A-16E schematically illustrates various examples of movementcapable of being performed by the removal device 100. In someembodiments, a distal portion of the removal device 100 may besteerable, as described elsewhere herein. The removal device 100 may beinserted to a location proximate one or more kidney stones. The distalportion of the removal device 100 may be moved in a lateral direction(e.g., left-to-right, right-to-left, upward, downward, or any directionthere between), as depicted in FIG. 16A, while applying aspirationand/or irrigation. In some implementations, the removal device 100 mayprovide aspiration and/or irrigation according to one of the patterns orprofiles described elsewhere herein during the lateral movement of thedistal portion. The removal device 100 may be moved in one direction ormay be moved back-and-forth in a reciprocating motion, as depicted inFIG. 16B. The removal device 100 may be moved in various differentintersecting trajectories, such as left-to-right, up-to-down, and/ordiagonals between those orthogonal directions, as shown in FIG. 16A.Lateral movement may be used to create a sweeping motion of the distalend of the removal device 100. The lateral movement may increase thearea or volume that is swept by the catheter 102 and may improve theefficiency of kidney stone removal.

Moving the distal portion of the removal device 100 in a lateraldirection may be accomplished by bending a distal length of the removaldevice 100 such that it curves away from a longitudinal axis defined bya proximal portion of the removal device 100. Providing a single bend inthe distal portion of the removal device 100 may cause aspiration ports116 and/or irrigation ports 136 formed in the distal portion of theremoval device 100 to alter their orientation as the distal portion ismoved, as shown in FIG. 16B. For example, aspiration ports 116 and/orirrigation ports 136 formed in a distal face of the catheter 102 suchthat they face a distal direction parallel with the longitudinal axis ofthe catheter 102 when unbiased may be turned toward a lateral directionsubstantially orthogonal to the longitudinal axis (of the unbiaseddevice) or some direction in between the longitudinal axis (0 degrees)and an orthogonal direction (90 degrees). In some implementations, theface may be turned even further (more than 90 degrees) such that it isfacing at least partially toward the proximal direction aligned alongthe longitudinal axis, as described elsewhere herein. In someembodiments, the removal device 100 may comprise one or more ports alonga lateral sidewall of the catheter 102 (e.g., an aspiration port 116).The one or more ports may be positioned along the length of thesteerable portion and/or proximal to the steerable portion. In someimplementations, kidney stone removal may be facilitated by bending thesteerable distal portion toward the side comprising a lateral aspirationport 116, as depicted in FIG. 16C. In some implementations, kidney stoneremoval may be facilitated by bending the steerable distal portion in adirection away from the side comprising a lateral aspiration port 116(180 degrees from the aspiration port 116). In some implementations,kidney stone removal may be facilitated by bending the steerable distalportion along a direction somewhere between the side comprising thelateral aspiration port 116 and the opposite side (between 0 degrees and180 degrees).

In some embodiments, the steerable distal portion of the removal device100 may be configured to bend in more than one direction. For example,the distal portion may have two bends that form curves in oppositedirections within the same plane. A distal portion having a least twobends may be configured to bend in a manner such that the distal face ofthe removal device 100 remains facing in a distal direction as thedistal portion is moved laterally (e.g., swept left-to-right), as shownin FIG. 16D. In some embodiments, a lateral port (e.g., an aspirationport 116) may be positioned in a steerable portion comprising a firstcurve or in a steerable portion comprising a second curve. In someembodiments, the lateral port may be positioned between first and secondcurves. In some embodiments, the distal steerable portion may beconfigured to form curves in different planes. In some embodiments, morethan two curves may be formed along the length of the distal steerableportion. In some embodiments, each curve may be independentlycontrollable, such that a user can modulate the degree of bending in theindividual curve, such as using a control mechanism on a proximal handle200. In some embodiments, the removal device 100 may be configured toassume a predetermined conformation comprising multiple curves uponactuation of a control mechanism. For example, activating the controlmechanism a certain amount may be configured to bend one curve a firstamount (e.g., number of degrees) in a first direction and to bend asecond curve a second amount (e.g., number of degrees) in a seconddirection.

In some embodiments, the removal device 100 or a portion of the removaldevice 100 may be rotated along the longitudinal axis of the removaldevice 100 while applying aspiration and/or irrigation. In someimplementations, the removal device 100 may provide aspiration and/orirrigation according to one of the patterns or profiles describedelsewhere herein during the rotation of the removal device 100. In someembodiments, the removal device 100 may comprise an inner component(e.g., a combined aspiration and irrigation catheter 102 or a vacuumtube 110) and an outer component (e.g., an outer sheath or an irrigationtube 130), as described elsewhere herein. The inner component and/or theouter component may be independently rotatable with respect to theother. In some embodiments, one or both of the components are rotatedduring aspiration and/or irrigation. If both components are rotated,they may be rotated in the same direction, at the same speed or atdifferent speeds, or in opposite directions, at the same speed or atdifferent speeds. In some embodiments, the entire removal device 100 isconfigured to be rotatable within the urinary tract. Rotation of theremoval device 100 or a portion of the removal device 100 may be usefulfor moving the distal end of the removal device 100 along a curvedtrajectory, such as an arc or a circle. For example, 360 degree rotationof the removal device 100 while a steerable distal portion is in a bentconfiguration will result in the distal tip of the removal device 100moving in a circular pattern centered around the longitudinal axis ofthe removal device 100, as depicted in FIG. 16E. More complextrajectories may be created by dynamically bending the steerable distalportion while rotating the removal device 100 or a portion thereofand/or while advancing the removal device 100 in a distal direction orretracting it in a proximal direction. The various features of themethods described herein may be combined in any feasible manner, suchthat more complex patterns of motion are achievable by the user. Thesepatterns of motion may be combined with the specific patterns ofaspiration and/or irrigation disclosed herein to create optimizedprocedures for the removal of kidney stones.

In some implementations, kidney stone removal may be optimized bystrategically positioning the catheter 102 proximate to a target kidneystone prior to providing suction and/or aspiration through the catheter102. Kidney stones may be removed by positioning the catheter 102 suchthat the target kidney stone is aligned with an aspiration port 116configured (e.g. sized) to remove the kidney stone. The aspiration port116 may be positioned on either a distal face or lateral side of thecatheter 102. For instance, the catheter 102 may be positioned such thatthe target kidney stone is positioned directly in front of the distalface of the catheter 102 comprising a distal-facing aspiration port 116.In some embodiments, the aspiration port may be positioned within orabout approximately 0.005 inches, 0.01 inches, 0.02 inches, 0.03 inches,0.04 inches, 0.05 inches, 0.06 inches, 0.07 inches, 0.08 inches, 0.09inches, 0.1 inches, 0.2 inches, 0.3 inches, 0.4 inches, 0.5 inches, 0.6inches, 0.7 inches, 0.08 inches, 0.09 inches, 1 inch, less than 0.005inches, or more than 1 inch away from the target kidney stone.Positioning the aspiration port to be aligned with the target kidneystone may comprise any one or more of the movements described herein,such as axially translating the catheter 102, rotating the catheter 102,and/or bending one or more distal portions of the catheter 102. Once theaspiration port 116 is positioned within an optimal alignment (e.g.,directly aligned) and range of the target kidney stone, aspirationand/or irrigation may be provided to capture the kidney stone.Irrigation may dislodge the target kidney stone, provide pressure toprevent suctioning of adjacent tissue into the suction path, and/or movethe kidney stone (e.g., toward the aspiration port 116). Suctioning maydraw the target kidney stone into the vacuum lumen 114 for removal. Oncesuctioning and/or irrigation are applied, the catheter 102 may not needto be moved or repositioned in order to remove the target kidney stone.The kidney stone may be removed from the body without removing thecatheter from the kidney. In some implementations, once the targetkidney stone is successfully aspirated, suctioning and/or irrigation maybe stopped. The catheter 102 may be subsequently repositioned (e.g.,while suctioning and/or irrigation are halted) in optimal alignment andrange for capturing a subsequent kidney stone. Positioning the catheter102 in optimal alignment and range may be advantageous in that itprevents the irrigation from moving the target kidney stone away fromthe catheter 102 prior to the aspiration port being in position tocapture the target kidney stone. In some implementations, a guidewire isfirst positioned adjacent or near a kidney stone (e.g., using directvisualization) and a flexible catheter 102 is subsequently guided intoposition via the guidewire, with or without direct visualization. Theflexible catheter 102 may be repositioned (e.g., in different calyces)using a guidewire and/or a scope for direct visualization. The guidewireand/or scope may be removed prior to initiation irrigation and/oraspiration. Steerable embodiments of the catheter 102 may be able toefficiently remove kidney stones without precise positioning and may bemore suitable for performing blindly (without direct visualization, butusing indirect visualization such as fluoroscopy and/or ultrasound).

In some embodiments, the target kidney stone is guided to the aspirationport 116. For instance, a shield or basket on an ancillary member, asdescribed elsewhere herein, may be used to guide the kidney stone towardan aspiration port 116 on the catheter 102. An ancillary irrigation tube130 may be used to push or direct a kidney stone toward the aspirationport 116 via an irrigation stream. The catheter 102 may remainrelatively stationary while the kidney stone is guided toward theaspiration port 116. In some embodiments, the operator may not be ableto visualize the kidney stones. The shield or other guiding device maybe used in a sweeping or scooping motion that would generally cover anentire area of a region (e.g., a pole or calyx) and ultimately guide anykidney stones to an optimal alignment and range in front of anaspiration port 116 of the catheter 102. In some embodiments, the kidneystone is guided to the aspiration port 116 using the catheter 102itself, such as by contacting the kidney stone with the catheter 102.The distal end 106 of the catheter 102 may be used to contact and guidethe kidney stone. In some embodiments, the catheter 102 may have asurface or otherwise be shaped (e.g., scoop shaped such as in FIG. 4G)to facilitate contacting and/or guiding the kidney stone. In someembodiments, the catheter 102 may include a shield member similar tothat described elsewhere herein. In some embodiments, the kidney stoneis guided to the aspiration port 116 using an irrigation stream comingfrom the irrigation port 136. In some implementations, the kidney stonemay be guided from a first position in the kidney to a second positionin the kidney. The second position in the kidney may be more optimal foraligning the aspiration port 116 with the kidney stone. For example, thekidney stone may be less prone to dislocation, such as under the forceof irrigation, in the second location than in the first location.Subsequent kidney stones may be moved from a third position to the firstposition or to a fourth position, which may be more optimal for aligningthe aspiration port 116 with the kidney stone than the third position.

Kidney stone removal may be optimized by strategically performingaspiration and/or irrigation in an ordered sequence across variouslocations. For example, kidney stone removal may be optimized byperforming a specific operation comprising a particular sequence ofmovements and/or a particular pattern of aspiration and/or irrigation ata location then moving the removal device 100 to a subsequent locationand performing another specific operation, which may be the same ordifferent from the first operation. This strategy may be repeated over aplurality of locations. In some embodiments, the therapeutic proceduremay be performed in a downstream direction. For example, a kidney stoneremoval operation may be performed in a minor calyx then retracted intothe major calyx where another operation is performed. The operation maybe repeated any number of times before moving to another location. Fromthe major calyx, the removal device 100 may be retracted into the renalpelvis where another operation may be performed. From the renal pelvisthe removal device 100 may be retracted into the ureter where anotheroperation may be performed. Any of the aforementioned locations may beexcluded. For example, a therapeutic aspiration and/or irrigationoperation may not be performed in the minor calyx and/or may not beperformed in the ureter. Any preceding and/or subsequent locations maybe combined with a given location such that the operative range ofmotion of the operation spans the two or more locations across which anoperation is performed before substantially repositioning the removaldevice 100. For example, a therapeutic aspiration and/or irrigationoperation may comprise a range of motion extending through both a majorcalyx and a minor calyx, such as a motion trajectory involvingreciprocation between the major calyx and the minor calyx. The proceduremay involve moving from branch to branch, wherein a branch comprises therenal pelvis, a major calyx, and an adjoining minor calyx, or a portionthereof. The procedure can be performed by moving to adjacent minorcalyces within a branch before moving to adjacent major calyces. In someembodiments, a downstream location may be repeatedly operated upon asvarious branches are traced. In some embodiments, a downstream locationmay only be operated upon after completion of all upstream locations. Insome embodiments, the same sequence of operations may be performed in areverse order. That is, a series of therapeutic aspiration and/orirrigation operations may be sequentially performed across variouslocations, generally moving in an upstream direction, such as from theureter, to the renal pelvis, to a major calyx, to a minor calyx.Procedures may be performed moving from branch to branch whileperforming therapeutic aspiration and/or irrigation operations in anupstream direction.

In some embodiments, a removal procedure is initiated with the catheter102 in a relatively distal position. Irrigation may be applied from thecatheter 102 prior to suctioning. In some embodiments, the irrigationmay advantageously generate a vortex effect. In some embodiments, theirrigation may generally fill, or at least partially fill, a major orminor calyx with irrigation fluid. Suctioning may then be provided asthe catheter 102 is retracted in a proximal direction. The distal end106 of the catheter 102 may be articulated to sweep the calyx or pole asthe catheter 102 is retracted. Suctioning may be provided intermittentlyduring the procedure. Irrigation may be provided continuously throughoutthe procedure. The procedure may be repeated as necessary. In otherembodiments, the same procedure is performed but the catheter 102 isadvanced distally during the procedure.

In some embodiments, the catheter 102 is positioned in each of the threekidney poles (upper, middle, and lower) and swept within each pole. Forinstance, the catheter may be distally advanced into one pole and thenthe distal end of the catheter 102 may be steered to sweep the area ofthe pole. After one pole is swept, the catheter 102 may be proximallyretracted then distally advanced into the next pole and the procedurerepeated. In some implementations, the catheter 102 may be swept inincremental steps. For instance, the distal end 106 of the catheter 102may be moved across a number of positions and stopped. Aspiration and/orirrigation may be stopped during steering/sweeping of the catheter 102and then applied for a duration of time while the catheter 102 ismaintained in constant position. The sweep pattern may be configured tocover substantially the entire pole. The sweep pattern may move in thesame direction as kidney stones tend to move under the force ofirrigation (e.g., in the direction of gravity), such that the finaldestination of the sweep pattern is a point of the pole where anynon-aspirated kidney stones are expected to have accumulated. In someimplementations, aspiration and/or irrigation may be applied during thesweeping movement or steering of the catheter 102. In someimplementations, the procedure may be performed in the upper pole,followed by the middle pole, and finally in the lower pole, as kidneystones may tend to be relocated and accumulate in the lower pole duringthe procedure. In other implementations, the procedure may be performedin the reverse order or the procedure may be performed in the middlepole then either the upper pole or the lower pole. In someimplementations, irrigation may be used to positively flush all thekidney stones into one pole (e.g., the lower pole) and then the removalprocedure may be performed in that pole. In some embodiments, kidneystones may be captured or guided into the catheter 102 using a shield orbasket device, such as described elsewhere herein. The shield or basketdevice may be most optimally used in a pole providing the straightestpath (e.g., the middle pole). In some embodiments, the pole with thestraightest path may be operated on last and/or a shield or basketdevice may be used in that pole.

In some implementations, the removal procedure may be performed withoutthe use of a ureteroscope or other direct visualization device, at leastduring the aspiration and/or irrigation portion of the procedure (whenthe kidney stone is removed). In some instances, blood produced using alaser for lithotripsy may obscure the visibility of direct visualizationmodalities. The procedure may be monitored using indirect visualizationsuch as fluoroscopy (e.g., via retrograde pyelogram) and/or ultrasound.Contrast agent may be introduced into the body (e.g., the kidney) viathe irrigation lumen or lumens 134 of the removal device 100. In someembodiments, a fiberoptic device (for direct visualization) may be usedduring the procedure. A fiberoptic lens may be carried on a thin wirethat is relatively thin relative to the dimensions of a scope (e.g., anendoscope or ureteroscope). A fiberoptic device may advantageously allowdirect visualization while minimally or negligibly reducing thedimensions of the vacuum lumen 114 such that large stones may besuctioned through the removal device 100. Fiber optic cables may run thelength of the catheter for introducing light to the in vivo space and/orcollecting light from the in vivo space (e.g., two fibers). Fiberopticsmay advantageously reduce the heat generated with the use of LED lightsources in traditional endoscopes. The camera for use with fiber opticsmay consume about 1 mm² of surface area or less and may be positioned ata distal end of the catheter 102 or at a proximal end (e.g., within thehandle 200). Kidney stones may not be visible under the indirectvisualization. The catheter 102 may comprise radiopaque materials (e.g.,a metal coil) and/or may include radiopaque marker bands, such as at adistal end of the device, so that the catheter 102 is visible underfluoroscopy. The distal end 106 of the catheter may be swept through arange of positions, as described elsewhere herein, where kidney stonesare expected to be located. The catheter 102 may be strategically sweptor repositioned along a direction that kidney stones are likely to havedislocated, as described elsewhere herein, in order to maximize theprobability of removing residual kidney stones. In some implementations,contrast agent may be used to monitor the removal procedure. Theaspiration (removal from the body) of the contrast agent may indicatethe location of the distal tip of the catheter 102 in real-time. Areaswhich do not contain contrast agent (e.g., are not visible) may beassumed to have already been aspirated. Thus, in some implementations,the aspiration procedure may be conducted until all or significantly allof the contrast agent is removed from the kidney, or at least form therenal calyces.

As an example of a removal procedure, a steerable catheter 102 may beused to sweep each calyx of the target kidney. The catheter 102 may benavigated into each of the major calyces or poles, using thesteerability to create an appropriate bend where required (as determinedunder fluoroscopy), within which a sweep procedure may be conducted. Theuser may be able to discern the placement of the distal end of thecatheter 102 into a target calyx via tactile feedback. For instance, theuser may sense less resistance on a lever that is being used toarticulate a bend in the catheter 102 and/or may observe less resistancein axially translating the catheter 102 (e.g., in a distal direction) asthe distal end enters a calyx. The calyces may be targeted in an upperto lower order (e.g., upper pole, middle pole, lower pole). The sweepprocedure may require initiating irrigation and suctioning if notalready being applied. In some embodiments, the distal end 106 of thecatheter 102 is introduced into the target calyx while suction andirrigation are being applied. In some embodiments, the distal end 106 isintroduced into the target calyx without either suction or irrigation.In some embodiments, the distal end 106 is introduced with irrigationbut without suction, such as when continuous irrigation is beingapplied. Suctioning may be prevented by disconnecting the vacuum source,by having the vacuum source in an off position, and/or by operation of asuction valve such as a finger port 228. In some embodiments, the calyxmay be sufficiently flushed with irrigation fluid prior to theinitiation of suctioning. Doing so may prevent the suctioning fromsticking to the kidney tissue and potentially injuring the tissue. Thepassive outflow of irrigation fluid through the finger port 228 oranother port in fluid communication with the kidney may be used toindicate that a sufficient amount of irrigation fluid has been deliveredto the target calyx. Once the calyx is sufficiently filled withirrigation fluid, suctioning may be initiated. The suctioning proceduremay be performed quickly enough such that the calyx is not emptied orthe fluid level within the calyx does not fall below a threshold level(e.g., to prevent sticking of kidney tissue to the catheter 102) duringthe sweep procedure. The suctioning may be approximately correlated tothe irrigation flow (e.g., it may remove the same volume of irrigationfluid as is delivered over a timeframe) or it may remove more or lessfluid than is being delivered. In some embodiments, a manual irrigationsource is used, such as a syringe, and the manual irrigation source canprovide feedback to the user regarding whether the catheter tip isobstructed. For example, if pressing on the syringe plunger isdifficult, that may indicate that the catheter tip is positioned againsttissue, such as kidney mucosa, or otherwise obstructed. Moving thecatheter distally a short distance can then free the catheter tip fromthe obstruction, as can be confirmed by the ease of infusing irrigationfluid (e.g., by the ease of pressing on a syringe plunger). Thus, someembodiments include utilizing feedback from the irrigation fluid flow toensure that the vacuum tube will be unobstructed for aspiration.

Once suctioning is applied, the target calyx (e.g., the major calyx) maybe swept to capture kidney stones. In some embodiments, the sweepcomprises bending the distal end 106 of the catheter 102 within thetarget calyx in one or more directions. In some embodiments, the sweepcomprises performing a complete revolution (360 degree) of the distalend 106 around a circular trajectory within the target calyx, the sameas or similar to that described with respect to FIG. 16E. To perform therevolution the distal end 106 of the catheter may be bent in a firstdirection within the target calyx. Bending the distal end 106 in thefirst direction may comprise increasing or decreasing an angle of anexisting bend in the catheter 102, which was imposed on the catheter 102to navigate the distal end 106 into the target calyx. The bend in thefirst direction may be accomplished using one or more levers (e.g.,levers 232, 233) on the handle 200, as described elsewhere herein, oranother type of steering member. Once the bend in the first direction isin place, the catheter 102 may be rotated by rotating the handle 200 ofthe removal device 100. In some implementations, the handle 200 andcatheter 102 may be rotated 360 degrees to complete the revolution. Insome implementations, the catheter 102 may be rotated about 180 degreesin a first direction (e.g., clockwise or counterclockwise) to positionthe distal tip of the catheter 102 opposite its starting positionrelative to the unbent (with respect to the additional bend in the firstdirection) portion of the catheter 102. The catheter 102 may then bebent in a second direction, substantially opposite the first direction,using one or more levers or another type of steering member, toreposition the distal tip of the catheter 102 roughly at its startingposition within the target calyx. The distal tip of the catheter 102will create additional sweeping motions along a semi-arc trajectory,substantially normal to the plane of the revolution during the bendingin the second direction. The amount of bending in the second directionmay be approximately twice the amount of bending (e.g. twice the angleof bend) as was applied when bending in the first direction. Thecatheter 102 may then be rotated in a second direction, opposite thefirst direction of rotation, about 180 degrees to complete the entirerevolution of the circular trajectory. Breaking the circular trajectoryinto two (or more) 180 degrees rotations in opposite directions maycomprise easier hand motions for the user to operate the handle 200 tocomplete the revolution. The handle and operation of the catheter 102may be designed so that the removal device 100 can be used in a highlyergonomic manner.

In some embodiments, the circular trajectory may be divided into morethan two rotating movements (e.g., 90 degrees movements). The completionof the circular trajectory may comprise tracking the distal tip overoverlapping portions of the trajectory. In some embodiments, thecircular trajectory may be repeated (e.g., 1, 2, 3, or more than 3times). The angle of the bending (e.g., in the first direction and thesecond direction) may be increased or decreased between repeatedmovements, such that the circular trajectory is larger or smaller andpositioned more proximally or more distally within the target calyx. Insome embodiments, the distal tip of the catheter 102 may be distallyadvanced or proximally retracted during and/or between repeatedtrajectory movements. In some embodiments, the distal tip is maintainedin constant movement within the calyx, at least during suctioning. Oncethe sweeping procedure is completed, the distal end 106 of the catheter102 may be withdrawn from the target calyx (e.g., by proximallyretracting the handle 200). In some implementations, irrigation may becontinually provided as the distal end 106 is withdrawn from the calyx.In some implementations, irrigation may be continually provided as thedistal end 106 is withdrawn and inserted into the next target calyx. Insome implementations, suction may be continually provided as the distalend 106 is withdrawn from the calyx. Application of suction duringwithdrawal from the calyx may capture any stones that might otherwisemigrate into the calyx during removal of the distal end 106, or at leastprevent the stones from migrating into the already swept calyx. Thedistal end 106 may be steered into the next target calyx and thesweeping procedure repeated. The steerability of the catheter 102 mayallow navigation of the distal end 106 into the next calyx underindirect visualization (e.g., fluoroscopy) without use of a guidewire ordirect visualization (e.g., an endoscope). The steerability may allowthe distal end 106 to be navigated into any of the major calyces withoutuse of a guidewire or direct visualization (e.g., an endoscope). Thesteerability may allow the distal end 106 to be navigated into any ofthe minor calyces without use of a guidewire or direct visualization(e.g., an endoscope). This sweeping procedure may be repeated until allof the kidney calyces have been swept. In some embodiments, each calyxis swept one time. In some embodiments, one or more of the calyces maybe swept multiple times.

During use of the catheter 102, the vacuum lumen 114 may become cloggedby stones and/or other debris which may prevent further aspiration ofstones. Some tests have shown that catheters 102 may tend to becomeclogged near the distal end and/or near stepped changes in diameterwithin the handle. Stones of relatively oblong shapes, jagged profiles,and/or groups of stone having mixed sizes and/or dimensions may beparticularly prone to causing clogs. The removal device 100 may includeone or more features configured to indicate the presence of a clog to auser. For example, the pressure within the vacuum lumen 114 proximal tothe obstruction should increase when the vacuum lumen 114 becomesclogged. The removal device 100 may include an electrical and/ormechanical pressure transducer or pressure gauge (e.g. a Bourdon tube)in fluid communication with the vacuum lumen 114 for monitoring pressurewithin the catheter 102 (e.g., proximal to the vacuum lumen 114). Apressure rise above a numerical level and/or above a marked level mayindicate the presence of an obstruction. In some embodiments, the usermay visually observe the indicated pressure rise and cease suctioning.In some embodiments, the removal device 100 may be configured toautomatically shut off the negative pressure source upon detecting arise above a maximum pressure (e.g., via the controller). In someembodiments, a simple binary mechanical indicator may alert the user ofthe presence of an obstruction. For example, the removal device 100 maycomprise a pressure band. The pressure band may be removably coupled orattached to the removal device 100 such as along an aspiration lineleading to the handle or any other suitable position configured toremain outside of the body. At least a portion of the pressure band maybe placed in fluid communication with the vacuum lumen 114 when thepressure band is attached to the removal device 100. For instance, thepressure band may comprise a ring shape having a slit along itscircumference that allows the pressure band to be placed over theaspiration line or a portion of the handle. The pressure band may beelastically deformable to fit over the aspiration line. The pressureband may be configured to cover and fluidly seal an opening in theaspiration line. When the pressure within the vacuum lumen 114 surpassesa threshold pressure, the pressure may elastically deform the pressureband causing it to decouple from the removal device, as an indicatorthat a clog has been detected. Once the obstruction is attended, theuser may reapply the pressure band, which may be reusable. In someimplementations, the clog may be audibly detectable. An operator may beable to audibly discern the difference between a higher flow rate whenthe vacuum lumen 114 is unclogged and a lower flow rate when the vacuumlumen 114 is clogged. The sound produced from aspiration may be louderwhen the vacuum lumen 114 is unclogged than when the vacuum lumen 114 isclogged. In some embodiments, the vacuum tube 110 (or a vacuum linecoupled to the vacuum tube 110 such as through a proximal fluid port 222of a handle 200) may comprise one or more small apertures that place thevacuum lumen 114 in fluid communication with the ambient environment.The apertures may be sized such that they do not significantly diminishthe flow rate of the aspiration through the vacuum lumen 114 and/orcreate a significant decrease in pressure. In some implementations, theapertures may be configured to produce (e.g., whistle) or amplify thesound of suctioning such that an operator can audibly detect thepresence of a clog.

In some embodiments, the catheter 102 may be moved through a prescribedrange of motions that allows cleaning or clearing the catheter 102 whenclogged, without removing the catheter 102 from the body. For instance,the catheter 102 may be moved into a position that substantiallystraightens the vacuum lumen 114 to remove any kinks and/or optimizepressure. The irrigation stream, in embodiments where possible, may bedirected toward the aspiration port 116 to maximize pressure within thevacuum lumen 114. The distal end 106 of the catheter 102 may be movedaway from tissue and the suction may be increased to de-clog the vacuumlumen 114. The vacuum lumen 114 may be temporarily placed in fluidcommunication with a positive pressure source (e.g., a syringe) ratherthan a negative pressure source, which may be temporarily turned off ordisconnected. The positive pressure source may force a fluid (e.g., airor irrigation fluid) distally through the vacuum lumen 114 to dislodgethe obstruction. The positive pressure may cause the obstruction to bemoved distally out of the distal end of the catheter 102. In someembodiments, the handle 200 may comprise an additional fluid port 222(e.g., a leur-connector port) for placing the vacuum lumen 114 in fluidcommunication with a positive pressure source. The catheter 102 may bewithdrawn from the body and manually unclogged. In some embodiments, anobturator, such as obturator 400 described elsewhere herein or anobturator similar thereto, may be used to dislodge the obstruction,either ex situ or in situ. The unclogging obturator may be received inthe vacuum lumen 114 through a proximal end of the removal device 100.The unclogging obturator may be used in situ (e.g., while the distal endof the catheter remains positioned inside the kidney) or on a catheter102 that has been removed from the body. The unclogging obturator may bethe same as or different from the obturator used to introduce thecatheter into the body, if an obturator is used during the introduction.For example, an unclogging obturator may be relatively stiffer along itslength than an introducing obturator to facilitate transmitting a distalpushing force on the obstruction. The unclogging obturator may beprovided together with the removal device 100 (e.g., as part of a kit)or as a separate component. The distal end of the unclogging obturatormay be flat, round, pointed, tapered, dome-shaped, bullet-shaped, etc.The unclogging obturator may comprise measurements or other markingsalong its length that are visible to a user along at least the portionextending from a proximal end of the removal device 100. The markingsmay indicate the relative distance into the catheter 102 that the distalend of the unclogging obturator has been inserted. A user may use themarkings to approximate the location of the obstruction within thecatheter 102. In some embodiments, the unclogging obturator may comprisea lumen (e.g., a central lumen) for receiving a guidewire. The guidewiremay be axially translatable relative to the unclogging obturator. Theguidewire may be used to exert force on the obstruction. The guidewiremay have a relatively large cross-sectional area (e.g., thecross-sectional area may be maximized) or a relatively smallcross-sectional area (e.g., the cross-sectional area may be minimized).In some embodiments, the vacuum tube 110 and/or the unclogging obturatormay be mechanically oscillated or vibrated to facilitate looseningobstructions. In some embodiments, the unclogging obturator (or pusher)may comprise a small diameter wire (relative to the inner diameter ofthe vacuum lumen 114) or at least a small diameter wire extendingdistally from a larger diameter elongate body. The small diameter wirehave sufficient rigidity to be pushed through the vacuum lumen and todislodge a clog. In some implementations, particularly during an in situunclogging, the small diameter wire may advantageously dislodge the clogand allow the debris (e.g., kidney stones) to continue to travelproximally through the vacuum lumen 114, since the small diameter wiredoes not substantially the entire cross sectional area of the vacuumlumen 114.

In some embodiments, a system is provided for guiding a clinicianthrough a procedure. The system may include a display (e.g., a computerscreen) for displaying information to the user. The display may be partof a controller, as described elsewhere herein. In some embodiments, thedisplay may depict an anatomical representation of the body lumen inwhich the procedure is performed (e.g., the urinary tract). The displaymay depict actual visualization information (e.g., video image)retrieved from an imaging device (e.g., a ureteroscope) orrepresentational information. The images may be real-time or obtainedprior to performing the procedure. For example, the images may beobtained from an imaging device inserted into or along side the removaldevice 100, as described elsewhere herein. In some embodiments, thedisplay may depict instructional information, textually or graphically(e.g., through symbols, pictures, or locations on a map) to theclinician. For example, the display may indicate the next physiologicallocation for performing an operation (e.g., the next calyx). Theanatomical location may be indicated on a map representation of thepatient. Locations already operated on, the most recently operated onlocation, the next location to be operated on, and/or locations yet tobe operated on may also be indicated (e.g., using different colors). Insome implementations, the user may interact with the system, such as byinputting completion of an anatomical location (e.g., marking achecklist), and/or by marking locations which are to be operated onduring or prior to the operation. The display or other portions of thesystem (e.g., a display on the device handle 200) may indicate operativevalues to the user. For instance, the display may indicate a pressure orflow value to the user, which, in some embodiments, may be modulated inreal time by the user, such as through a button or finger port on thehandle 200. In some embodiments, the system guides a clinician throughthe procedure by providing audio signals or instructions. For example,tones or verbal instructions may be provided to indicate that theclinician should perform a particular irrigation or aspiration sequence,move the catheter through a specific series of movements, or move to adifferent anatomical location.

In some embodiments, the removal system and/or removal device 100 maycomprise a catheter 102 comprising suction and optionally irrigation, asdescribed elsewhere herein, and an additional component configured to bepositioned adjacent the catheter 102 within the body (e.g., the urinarytract). In some embodiments, the adjacent component may be coupled tothe catheter 102 along the length of the catheter 102, along a portionof the length of the catheter 102, along a proximal portion of thecatheter 102, and/or at the handle (e.g., sharing the same handle orhaving a separate handle coupled to the catheter 102 handle). In someembodiments, the adjacent component may not be coupled to the catheter102 but may be delivered adjacent the catheter 102, simultaneously withthe catheter 102, prior to delivering the catheter 102, or afterdelivering the catheter 102.

FIGS. 17A-17E schematically illustrate various examples of theadditional component configured to be positioned adjacent the catheter102. In some embodiments, the adjacent component may be a safetyguidewire 302, as shown in FIG. 17A, which may be the same or similar tosafety guidewires, particularly those for use in urology, known in theart. The safety guidewire 302 may provide, for example, quick emergencyaccess to the urinary tract (e.g., the ureter or kidney) withoutnecessitating the removal of the catheter 102 (which may provide accessfor a visualization tool, such as a ureteroscope, during an emergencyprocedure).

The safety guidewire 302 may also be used to introduce ancillary toolsfor use during the routine procedure (e.g., kidney stone removalprocedure). In some embodiments, the safety guidewire 302 may be used tointroduce or may be integral with an irrigation tube 130. The irrigationtube 130 may comprise a separate lumen, as described elsewhere herein,for receiving the safety guidewire 302 and a separate lumen forproviding irrigation fluid or the irrigation lumen 134 may be used toreceive the safety guidewire 302. The irrigation lumen 134 may have across sectional area larger than the cross-sectional area of the safetyguidewire 302. The ancillary irrigation tube 130 may be the same as orsimilar to irrigation tubes 130 described elsewhere herein or comprisethe same or similar features as irrigation lumens 134 describedelsewhere herein. For example, the ancillary irrigation tube 130 maycomprise distal irrigation ports 136 and/or lateral irrigation ports136. The irrigation flow through the ancillary irrigation tube 130 maybe controlled separately from irrigation and/or aspiration through thecatheter 102 or may be by synchronized with the irrigation and/oraspiration through the catheter 102 according to any of the patternsdescribed elsewhere herein. In some embodiments, the ancillaryirrigation tube 130 may be advanced distally or retracted proximallyrelative to the catheter 102, such that irrigation stream of theancillary irrigation tube 130 may be dynamically positioned relative tothe one or more aspiration ports 116, such as during aspiration. In someembodiments, the ancillary irrigation tube 130 may be steerable (e.g.,comprise a steerable distal portion) as described with respect to thecatheter 102 elsewhere herein. Movement of the ancillary irrigation tube130 in an axial, lateral, and/or rotational direction may be used tocreate more complex arrangements of the ancillary irrigation tube 130with respect to the one or more aspiration ports 116 of the catheter102. For example, the ancillary irrigation tube 130 may be bent in asubstantially “c” shape configured to direct an ancillary irrigationstream toward the aspiration port 116 (e.g., from a lateral direction ora proximal and lateral direction), as schematically depicted in FIG.17B. The ancillary irrigation tube 130 may be dynamically repositionedduring the removal procedure. The ancillary irrigation tube 130 may bemoved while the catheter 102 remains static or may move simultaneouslywith movement of the catheter 102, according to any of the motionsdescribed elsewhere herein. In some embodiments, the use of an ancillaryirrigation tube 130 may allow use of a catheter 102 comprising noirrigation lumens 134. A catheter 102 comprising no irrigation lumens134 may optimize the space available for the vacuum lumen 114 of thecatheter 102, which may advantageously increase the suction generated bythe catheter 102.

In some embodiments, the safety guidewire 302 may be used to introduce ashield 304 or may be integral with a shield 304. In some embodiments,the shield 304 may be positioned at the distal end of a tube comprisinga lumen configured to receive and be advanced over the safety guidewire302. In some embodiments, the shield 304 may comprise a mesh configuredto allow fluid passage through the shield 304. The size of the mesh maybe configured to prevent passage of kidney stones through the shield304. In some embodiments, the mesh size may configured to contain ortrap kidney stones of a certain size (e.g., large or medium) but toallow passage of kidney stones of a smaller size. In some systems,various shield 304 components of different configurations (e.g., meshsize, shield 304 shape, etc.) may be selectable to use with the catheter102. The shield 304 may prevent movement of kidney stones from one calyxto another calyx. The shield 304 can make the use of irrigation whichstirs up debris such as kidney stones more effective. In someimplementations, the shield 304 may be configured to prevent the escapeof kidney stones that have been moved (e.g., under the force ofirrigation) toward one or more aspiration ports 116. For example, theshield 304 may be positioned on a proximal side of an aspiration port116, as illustrated in FIG. 17C. In some embodiments, an edge of theshield 304 may intersect directly with or adjacent to an edge of anaspiration port 116 (e.g., a proximal edge of an aspiration port 116),such that the shield 304 guides kidney stones and/or other debris towardthe aspiration port 116. The shield 304 may be configured with a conicalshape or other curved shape. The shield 304 may have an increasingdiameter or span as it extends in a distal and/or radially outwarddirection. In some embodiments, the shield 304 may be joined to thesafety guidewire 302 or tube member (e.g., at a proximal end) around aportion of the circumference of the safety guidewire 302 or tube (e.g.,45 degrees, 90 degrees, 135 degrees, 180 degrees, 224 degrees, 270degrees, etc.). The shield 304 may not be joined to the safety guidewire302 or tube member along a portion of the circumference configured tosit or be positioned adjacent to the catheter 102, such that the shield304 does not interfere with positioning the catheter 102 and ancillarydevice side-by-side. The circumferential span may remain constant,increase, or decrease as the shield 304 extends from the junctionbetween the shield 304 and the tube member or guidewire. In someembodiments, the shield 304 may be configured to effectively wrap aroundthe catheter 102, as shown in FIG. 17D, such that the shield 304 canextend along a greater portion or the entirety of the circumference ofthe catheter 102. In some implementations the shield 304 may beconfigured to wrap around the catheter 102 at a proximal portion of thecatheter 102 positioned outside of the body and the shield 304 may serveto couple the ancillary device to the catheter 102. The shield 304 maybe configured to be advanced (e.g., may slide) along the catheter 102 asit is introduced into the body. In some embodiments, the shield 304 maybe positioned such that a distal end of the shield 304 extends beyondthe distal end of the catheter 102. In some embodiments, the shield maycurve inward toward the longitudinal axis or crossing the longitudinalaxis of the catheter 102. The shield 304 may extend at least partiallyin front of a distal face of the catheter 102. In some embodiments, theshield 304 may have a curved or scooped shape.

In some embodiments, the shield 304 may have a collapsed configurationfor introduction into the urinary tract an expanded configuration inwhich the shield 304 has a larger diameter and/or cross-sectional area,such as for use in the kidney (e.g., the renal pelvis, the major calyx,the minor calyx, etc.). FIG. 17E depicts an example of the shield in acollapsed configuration. The expansion and/or collapse of the shield 304member may be controlled by pull wires 230, similar to those describedelsewhere herein, or any other suitable mechanism, such as those knownin the art. For example, a rod may be positioned within the tube member305 of the shield device. The rod may be coupled to a distal end of theshield 304 such that advancement and retraction of the rod increases anddecreases an effective length of the rod and expands and collapses theshield 304, respectively. The effective length of the rod may betransiently fixed using a screw mechanism or other suitable mechanismfor holding the shield 304 in a particular configuration. In someembodiments, the effective length of the rod may be increased ordecreased by rotating the rod. In some embodiments, the shield 304 maybe fixed in a collapsed configuration, and expanded configuration, or inany intermediate configuration there between.

In some embodiments, the shield 304 may be solid. The shield 304 may beeither rigid or flexible. In some embodiments, the shield 304 maycomprise a metal material. In some embodiments, the shield 304 maycomprise a polymer material or a polymer material may be used to coatthe shield 304. In some embodiments, the shield 304 may be joined to thesafety guidewire 302 or tube member 305 at a distal point and expand ina proximal and/or radially outward direction. For instance, the shield304 may be positioned distally of an aspiration port 116, as illustratedin FIGS. 17C-17E. Irrigation may be directed in a substantially distaldirection toward the aspiration port 116. In some embodiments, theshield 304 member may be coupled to or integrated with the ancillaryirrigation tube 130 or other ancillary device. In some embodiments, theancillary device may be a visualization device, such as a ureteroscope,which may facilitate visualization of the removal procedure.

FIGS. 18A-18B illustrate images of a distal end 106 of an embodiment ofthe removal device 100. The distal end 106 may be the same as thatdepicted in FIG. 1. In some embodiments, the distal end 106 comprises alateral aspiration port 116 and no distal-facing aspiration port. Thedistal end may have an atraumatic shape such as a rounded, domed, orbullet-shaped configuration. In some embodiments, the distal end 106 mayhave a flared or expanded diameter relative to a proximal portion of thecatheter 102.

FIGS. 19A-19H schematically depict various positions of guidewires,delivery sheaths, and catheter 102 of the removal device 100 in akidney. In some implementations, these positions may depict a generalsequence of positions assumed by the devices throughout a kidney stoneremoval procedure. Various steps may be altered, omitted, and/orreordered. Additional positions not shown may also be employed. In someimplementations, the kidney may first be inspected via a ureteroscope orother endoscope. The ureteroscope may be advanced into the kidney via aguidewire. The ureteroscope may be used to locate and/or count thekidney stones within the calyces of the kidney. In some implementations,a lithrotripsy device (e.g., a laser) may be inserted through theureteroscope and used to break apart the kidney stones into smallerfragments. The ureteroscope may be removed prior to the next steps. Insome implementations, a guidewire may remain positioned within thekidney.

FIG. 19A depicts the insertion of a first guidewire into the kidney(e.g., a major calyx or pole of the kidney). The guidewire may be asafety guidewire 302, as shown and described elsewhere herein, or may bea primary guidewire 101 for delivery of the removal device. FIG. 19Bdepicts the insertion of a second guidewire into the kidney. The secondguidewire may be a primary guidewire 101 as shown, or a safety guidewire302. The first and second guidewires may be positioned within the samepole of the kidney, as shown, or may be positioned in different poles.FIG. 19C depicts the insertion of a delivery sheath 103 through theureter. A delivery sheath 103 may be advanced over the primary guidewire101 for introducing the catheter 102 into the urinary tract. Thedelivery sheath 103 may be advanced to a position such as the ureter,the renal pelvis, or past the renal pelvis. In some implementations, thedelivery sheath 103 may be omitted altogether. The catheter 102 may beintroduced via a guidewire. In some implementations, the catheter 102may be introduced with the aid of an obturator, such as obturator 400described elsewhere herein. The obturator may be received through thevacuum lumen 114 or another lumen of the catheter 102. The obturator maycomprise a lumen for receiving the guidewire. The obturator may serve tofill the space or at least a portion of the space between the guidewireand the sidewall of the catheter 102, which may make it easier to trackthe catheter 102 over the guidewire. After the catheter 102 ispositioned (e.g., within the kidney) the obturator may be proximallywithdrawn, with or without the guidewire, so that the vacuum lumen 114may be used for aspiration. FIG. 19D depicts the advancement of thecatheter 102 distally beyond the distal end of the delivery sheath 103.In some embodiments, the catheter 102 may be advanced over the primaryguidewire 101, as shown and as described elsewhere herein. In someembodiments, the catheter 102 may be advanced beyond the delivery sheath103 without the use of the primary guidewire 101. The distal portion 106of the catheter may be sufficiently steerable to navigate the catheter102 beyond the delivery sheath 103 without the use of the primaryguidewire 101. In some embodiments, the primary guidewire 101 may beremoved from the delivery sheath 103 prior to advancement of thecatheter 102. FIG. 19E depicts the catheter 102 being used to providesuctioning and irrigation in the upper pole. FIG. 19F depicts therepositioned catheter 102 providing suctioning and irrigation in thelower pole. The safety guidewire 302 may be repositioned substantiallysimultaneously with, prior to, or subsequently to the repositioning ofthe catheter 102. In some embodiments, the catheter 102 may berepositioned with the use of the primary guidewire 101. The primaryguidewire 101 may be reinserted into the catheter 102, as describedelsewhere herein, with or without an obturator, for repositioning thecatheter 102 or, if never removed, may be advanced distally within thecatheter 102. In some embodiments, the catheter 102 may be repositionedwithout the use of the primary guidewire 101. The catheter 102 may berepositioned by proximally retracting and/or distally advancing thecatheter 102; by steering a distal end 106 of the catheter 102; and/orby rotating the catheter 102. FIG. 19G depicts the repositioning of thesafety guidewire 302 to be substantially adjacent to catheter 102. FIG.19H depicts the advancement of an ancillary device such as an irrigationtube 130 over the safety guidewire 302, as described elsewhere herein.As shown in FIG. 19H, the ancillary irrigation tube 130 may be used toadvantageously direct irrigation fluid toward an aspiration port 116,such as a lateral aspiration port 116. In some embodiments, a safetyguidewire 302 may be advanced into the kidney only when needed, such asafter the advancement and potentially the initial use of the catheter102. The devices may be removed from the body in any suitable order. Forinstance, the catheter 102 may be retracted into the delivery sheath 103and removed together from the body. The ancillary device and/or safetyguidewire 302 may be removed from the body following the removal of thecatheter 102 or vice-versa.

In some embodiments, the catheter 102 may comprise a preformed shape (anon-linear shape). For instance, the distal end 106 of the catheter maybe preformed with a curve. The pre-shaped catheter 102 may be steerableor non-steerable. The shape may resemble a shape of any configuration ofa J-catheter for example. For example, the shape may resemble that of aShirey transvascular catheter, a Brockenbrough transeptal catheter, asoftip coronary catheter, hockey stick catheter, an Amplatz catheter, anEBU or Left Graft catheter, a IMA or XBRCA catheter, etc. In someembodiments, the catheter 102 may comprise a shape memory material(e.g., nitinol or another shape memory metal or a shape memory polymer),at least a long the pre-shaped portion. The transition temperature maybe configured such that the catheter 102 assumes its preformed shape atphysiological temperature, at room temperature, some temperaturebetween, or below room temperature. In some implementations, the usermay be able to customize the shape prior to use of the catheter 102 inthe body. The shape of the catheter 102 may be reformable (e.g., byheating). The catheter 102 may cooperate with an outer sheath that isused to modulate the shape of the catheter 102. The outer sheath may besubstantially linear or at least a shape different from the pre-formedcatheter (e.g., straighter than the preformed catheter 102). The outersheath may be more rigid than the flexible pre-shaped catheter 102 andmay control the shape of the catheter 102, at least along portions ofthe length in which it surrounds the catheter 102. Thus, the shape ofthe pre-shaped catheter 102 may be effectively controlled (e.g.,effectively straightened) by advancing the outer sheath over the shapedportion of the pre-shaped catheter 102. The adjustability of the shapemay be used to facilitate navigating the pre-shaped catheter 102 intothe calyces of the kidney. For example, the catheter 102 may beintroduced through the ureter along with the outer sheath such that thecatheter 102 is straight. Once the distal end 106 of the catheter 102 ispositioned in the renal pelvis, the outer sheath may be retractedrelative to the catheter 102 and/or the catheter may be advancedrelative to the outer sheath to expose the pre-curved portion of thecatheter 102. The catheter 102 may assume a tighter bend (smaller radiusof curvature) the larger the length of the catheter 102 that is exposedfrom the outer sheath. Thus, the appropriate angle of bend may beachieved by selectively extending the catheter 102 from the outer sheatha given distance. The appropriate angle of bend may be chosen fornavigating the catheter into each of the calyces.

In some embodiments, a stone collection container or line-trap may bepositioned in-lie between the vacuum source and the handle 200 of theremoval device. The collection trap may be configured to collect kidneystones that are aspirated through the removal device 100. For example,the collection trap may comprise a closed container (maintaining thevacuum seal) in which an inlet line extends from the handle 200 to thecollection strap (it may extend into the collection trap) and an outletline extends from the collection trap to the vacuum source (it mayextend into the collection trap). The outlet line may be positioned at atop end of the collection trap or elsewhere on the collection trap. Theinlet line may be positioned at a top end of the collection trap.Gravity may be used collect stones in the bottom of the collection trap.For example, the collection trap may substantially resemble the stonecatcher of the Lithoclast Ultra Collection Device™. The collection trapmay be used to evaluate the removed stones and/or for reconciliation(e.g., counting or weighing) of the collected stones to determine theefficacy or completion of the treatment. In some embodiments, thecollection trap may be positioned upstream of an aspiration line. Forexample, the collection trap may be connected directly to or positionednear a hospital wall-mounted suction outlet. The collection trap may beself-supporting and may rest on the ground or a cart or may be supportedby the wall when attached to a wall outlet. There may be a sufficientlength of flexible aspiration line between the collection trap and theremoval device 100. In some embodiments, the collection trap may berigidly attached to the handle of the removal device 100. For instance,the collection trap may be supported on a proximal end of the handle andmay connect to a fluid port 222. An aspiration line may extend from thecollection canister to the negative pressure source. In someembodiments, the collection canister may be disposable. In someembodiments, the collection canister may be reusable. The collectioncanister may be used with a disposable interior liner if reused that maymake disposal of the contents after a procedure readily disposable.

In some embodiments, the collection trap may comprise indicatorsconfigured to provide information related to the weight, color, and/orsize of the collected stones. For example, the collection trap mayinclude one or more size filters (e.g., meshes). A size filter may bepositioned at the outlet (which may, for example, be positioned at thebottom end of the device rather than the top end) which allows only forthe collection of stones greater than a threshold size. Alternatively,one or more size filters may be positioned at the bottom of thecollection trap such that smaller stones fall deeper into the bottom ofthe collection container, while larger stones are collected closer tothe top of the container. The one or more filters may act to effectivelysieve the collected stones. In some embodiments, the collection trap orat least a portion thereof (e.g., a bottom portion) is configured torotate and may act as a centrifugal force trap. In some embodiments, thecollection trap may be coupled to a scale that monitors the mass of thecollected stones within the collection trap. In some embodiments,reagents (e.g., colorimetric reagents) may be stored in the bottom ofthe collection trap and may react with the collected stone to produceobservable colorimetric changes depending on a property (e.g., achemical property) of the collected stones. In some embodiments, thecollection trap (which may be at least partially transparent) may becoupled to a spectrophotometer, fluorescence detector, or other opticmeasurement device. Assessing color information about the irrigationfluid may be useful for determining physiological information such aspotential hematuria in the kidney. The collection trap may be used tomonitor outflow from the kidney and thereby provide an additional safetymechanism. Other suitable indicators may be used as well.

FIGS. 20A-20D schematically illustrates the dimensions and configurationof an example of an obturator 400 configured to be used with the removaldevice 100. FIG. 20A illustrates a side view of the obturator 400. FIG.20B illustrates a distal end view of the obturator 400. FIG. 20Cillustrates a cross section of a proximal end of the obturator 400. FIG.20D illustrates a cross section of a distal end of the obturator 400.The obturator 400 may be configured to be received within the vacuumlumen 114 of the vacuum tube 110. The obturator 400 may comprise atapered distal end 406, as shown in FIGS. 20A and 20D. The obturator 400may comprise a fluid port, such as a luer fitting (e.g, a clearpolycarbonate female luer fitting) at its proximal end 404. Theobturator 400 may comprise a lumen 402 extending from the proximal end404 to the distal end 406. The lumen 402 may be configured for receivinga guidewire. In some embodiments, the obturator (e.g., over a guidewire)may be used to facilitate in placing the catheter 102 in the kidney andpotentially at least in one of the target calyces (e.g., the initialtarget calyx) before being removed. The obturator may be relativelyflexible. For example, the obturator may be about 25D, 30D, 35D, 40D,less than 25D, more than 40D, or a durometer selected from a range therebetween. In some embodiments, the obturator may comprise PEBAX® oranother suitable material. In some embodiments, the obturator 400, orportions thereof, may be translucent. In some embodiments, the obturator400, or portions thereof, may be radiopaque. The obturator 400 may beconfigured to lock into place with the handle 200 of the removal device.The obturator 400 may comprise one or more wings 403 at the proximal end404.

In some embodiments, the catheter 102 and/or the obturator 400 may beconfigured to vibrate. In some implementations, vibrations from theobturator 400 may be transferred to the catheter 102 when the obturator400 is inserted, at least partially, into the catheter 102. Vibration ofthe catheter 102 and/or the obturator 400 may facilitate navigation ofthe removal device 100 through the urethra, ureter, and/or other bodycanals, particularly where the body canal is narrow and/or tortuous.Vibration of the catheter 102 and/or an obturator 400 inserted throughthe catheter 102 to a location proximal to a clog in the vacuum lumen114 may help dislodge a clog in the lumen 114. In some embodiments, thehandle 200 may comprise a motor or other electromechanical mechanism forinitiating the vibrations. In some embodiments, an ancillary vibratorydevice may be coupled outside of the body to a proximal end of thecatheter 102 (e.g., distal to strain relief 226) and/or proximal end ofthe obturator 400 (e.g., proximal to handle 200). With respect to thecatheter 102, the vibratory device may vibrate the vacuum tube 110and/or the irrigation tube 130. The vibrations may propagate from aproximal end of the shaft(s) toward a distal end of the shaft(s). Insome embodiments, the sidewall of one or more shafts may compriserelatively rigid elements (e.g., structural support elements such ascoils) which are prone to vibration. For example, the rigid elements maybe metal (e.g., stainless steel). These rigid elements may extend from aproximal end to or toward a distal end of the shaft(s). In someembodiments, the vibration may be applied directly to the rigid element.For instance, in some embodiments, the rigid element may protrudeproximally from the polymer layers of the sidewall of the one or moreshafts.

The embodiments disclosed herein are not necessarily limited to use forremoval of kidney stones and/or removal of kidney stones from the kidneythrough the ureter. For example, the devices, systems, and methodsdescribed herein may also be applied to applications such as nephroscopyand percutaneous nephrolithotomy, in which stones are moved via apuncture wound in the kidney through a minimally invasive procedure. Insome implementations, the size (e.g., diameter) of the removal device100 may be increased (e.g., an outer diameter of 10 mm or grater) ifused percutaneously to accommodate larger stones and/or to accommodate adirect visualization device (e.g., a ureteroscope). The removal device100 may comprise the same or similar functionalities, includingsteerability.

Example

A prototype removal device was tested in a live pig model. Notably, apig kidney has a more tortuous anatomy withshallower/shorter/narrower/smaller calyces than a human kidney, which isexpected to make isolation of stones within the pig calyces moredifficult since they can easily escape from the calyx during theprocedure. Pigs also have more calyces than humans. Also, the upper andlower poles of the pig kidney are oriented at significantly more severeangles to the ureter than the angles of a human kidney. The prototypecomprised a steerable distal portion and a single distal-facingaspiration port in fluid communication with a single finger port suctionvalve on the handle for controlling suctioning. The 12 Fr cathetercomprised a large aspiration lumen concentrically surrounded by anirrigation lumen.

A female pig was positioned in a supine or flat position (not in aTrandelenburg or reverse Trandelenburg position). Cystoscopy andureteroscopy (with a flexible Storz™ ureteroscope) were initiallyperformed on the pig subject. The procedure was also monitored underfluoroscopy using a contrast agent. A 0.035 inch sensor guidewire wasplaced into the target kidney. A 36 cm 12/14 Fr (inner diameter/outerdiameter) access sheath was introduced. An obturator was inserted intothe aspiration lumen of the catheter and the obturator and catheter wereadvanced over the guidewire. In some test runs, the catheter wasadvanced into the target calyx of the right or left pig kidney, and,upon placement of the catheter, the guidewire and obturator were removedfrom the catheter to measure the time required to successfully deliverthe device (the deliverability). In other test runs, kidney stonefragments sized approximately 1 mm and 2 mm, or aluminum balls of thesame size, were loaded into the target calyx via a basket using theaccess sheath, the scope, and/or the obturator. The placement within thecalyces of the kidney were confirmed via ureteroscope, after which aguide wire was introduced into the calyx and the scope was removed. Thealuminum balls were shaped into more oblong conformations that moreaccurately reflect stone fragments, since perfectly spherical objectsare expected to be more difficult to aspirate. The aluminum balls arevisible on fluoroscopy and allowed tracking of the migration of theballs. The balls were reported to float more easily than human kidneystones and to more readily migrate from their original location thanhuman kidney stones. The successful placement of the kidney stonefragments in the target calyx was inspected and confirmed via theureteroscope. The catheter was then advanced over the guidewire into thetarget calyx and the obturator and guidewire were removed. The catheterwas connected to a syringe (Boston Scientific Single Action PumpingSystem or SAPS™) as a source of irrigation and a vacuum sourcegenerating a pressure of 150 mm Hg and continuous irrigation (10 cc at atime) and suction, modulated by the physician via the finger hole, wereinitiated within the target calyx to collect the kidney stone fragmentsunder a blind procedure (the kidney stone fragments are not visible viafluoroscopy). The small amount of irrigation fluid delivered was removedwith each cycle of suctioning to prevent over-pressurization of thekidney. During the procedure with the human kidney stones, each calyxwas swept under fluoroscopy moving from the upper calyx to the lowercalyx. Contrast agent was used to facilitate improved visualization ofthe kidney's anatomy. Upon completion of a sweeping procedure, thecatheter was removed from the pig and the stone fragments captured werecollected from the aspiration waste and counted. The catheter wasinspected for any clogging or kinking. The ureteroscope was reintroducedinto the kidney and the kidney was inspected for tissue damage andresidual stones.

In a first test, 6 out of 10 2 mm aluminum balls were successfullyplaced in the upper, middle, and lower calyces of the left kidney.Several of the stones had quickly migrated from the middle calyx to thelower calyx. The 10 aluminum balls comprised a mass of 95 mg. Initially,the aluminum balls were attempted to be removed using a flexiblecatheter of similar construction as described above, except that thecatheter was non-steerable. The flexible catheter was unable to accessany of the pig calyces at its given flexibility. Irrigation flowpressure was increased to attempt to create a vortex effect from withinthe renal pelvis. The non-steerable catheter removed 0 of 6 aluminumballs after applying 200 cc of total irrigation volume. The procedure,from the initiation of suction and irrigation to the removal of thecatheter lasted 3 minutes 10 seconds. The procedure resulted inadditional migration of the stones, including one stone to the uppercalyx and another deep into the lower calyx. Afterwards, removal wasattempted using the steerable catheter. A total irrigation volume of 240cc was applied and 4 of the 6 aluminum balls were successfully removedfrom the calyces without any clogging of the catheter. The two unremovedaluminum balls were those that had migrated during the procedure withthe non-steerable catheter. The procedure, from the initiation ofsuction and irrigation to the removal of the catheter lasted 2 minutes50 seconds.

In a second test, 9 out of 10 2 mm stone fragments were successfullyplaced in the middle calyx, with a few of the fragments quicklymigrating to the upper calyx of the right kidney. The 10 fragmentscomprised a total mass of 67 mg. A total irrigation volume of 120 cc wasapplied and 9 of the 9 stone fragments were successfully removed fromthe calyces without any clogging of the catheter. The procedure, fromthe initiation of suction and irrigation to the removal of the catheterlasted 2 minutes 15 seconds.

In a third test, 8 of 10 stone fragments were successfully placed in theupper and middle calyces of the right kidney—2 in the upper calyx and 6in the middle calyx. The 10 fragments comprised a total mass of 67 mg. Atotal irrigation volume of 250 cc was applied and 8 of the 8 stonefragments were successfully removed from the calyces without anyclogging of the catheter. The procedure, from the initiation of suctionand irrigation to the removal of the catheter lasted 3 minutes 10seconds.

The catheter was able to access all of the kidney's calyces within aspan of 30 seconds. The catheter was able to be easily navigated intothe anterior and posterior calyces of each major calyx. The physicianwas able to confirm minimal tissue damage during the procedure bymonitoring the color (i.e. the amount of blood) in the irrigation fluidthat exited via the finger port via passive outflow when the kidneypressure rose with the addition of the irrigation fluid. No perforation,tearing, or bleeding of the kidney was observed to be associated withthe procedure. Safe suctioning within the kidney was achieved with usingno more than 240 cc irrigation fluid in each procedure.

The tests showed that the procedure was successfully performed with nodirect visualization using a scope, under standard fluoroscopy. Usingfluoroscopy, the physician was able to access each calyx within 30seconds and the entire procedure took an average of 2 minutes tocomplete. The absence of a scope inside the aspiration lumen during theprocedure was highly advantageous in that it maximized the patency ofthe aspiration lumen during aspiration. The absence of a scope isexpected to allow larger fragments to be removed than when a scope isused. The physician noted the steerable catheter was easy to use andsimilar to operating a flexible ureteroscope.

It is understood that this disclosure, in many respects, is onlyillustrative of the numerous alternative device embodiments of thepresent invention. Changes may be made in the details, particularly inmatters of shape, size, material and arrangement of various devicecomponents without exceeding the scope of the various embodiments of theinvention. Those skilled in the art will appreciate that the exemplaryembodiments and descriptions thereof are merely illustrative of theinvention as a whole. While several principles of the invention are madeclear in the exemplary embodiments described above, those skilled in theart will appreciate that modifications of the structure, arrangement,proportions, elements, materials and methods of use, may be utilized inthe practice of the invention, and otherwise, which are particularlyadapted to specific environments and operative requirements withoutdeparting from the scope of the invention. In addition, while certainfeatures and elements have been described in connection with particularembodiments, those skilled in the art will appreciate that thosefeatures and elements can be combined with the other embodimentsdisclosed herein.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A method of removing kidney stones from a kidneyof a patient, the method comprising: inserting a steerable distalportion of a catheter system through the urethra, bladder, and ureterand into the kidney, the distal portion comprising a vacuum lumen and anirrigation lumen, wherein a distal face of the distal portion comprises(i) an aspiration port and (ii) a plurality of irrigation ports in fluidcommunication with the irrigation lumen, wherein the aspiration port hasan inner diameter larger than the inner diameter of any one of theplurality of irrigation ports; irrigating the kidney by applyingirrigation fluid at a flow rate in a first flow rate range through theirrigation lumen and out from at least one of the irrigation ports;inserting the distal portion into a first calyx of the kidney; applyingirrigation fluid at a flow rate in a second flow rate range through theirrigation lumen and out from at least one of the irrigation ports;removing kidney stones from the first calyx by applying suction throughthe vacuum lumen; applying irrigation fluid at the flow rate or adifferent flow rate in the second flow rate range through the irrigationlumen and out from at least one of the irrigation ports; steering thedistal portion within the first calyx by manipulating a wire pull memberof a proximal handle portion of the catheter system, the wire pullmember attached to a plurality of pull wires running from the distalportion to the wire pull member, wherein pulling on one or more the pullwires using the wire pull member causes the distal portion to bend;removing the distal portion from the first calyx; inserting the distalportion into a second calyx of the kidney; applying irrigation fluid atthe flow rate or a different flow rate in the first flow rate rangethrough the irrigation lumen and out from at least one of the irrigationports; removing kidney stones from the second calyx by applying suctionthrough the vacuum lumen; applying irrigation fluid at the flow rate ora different flow rate in the second flow rate range through theirrigation lumen and out from at least one of the irrigation ports; andsteering the distal portion within the second calyx by manipulating thewire pull member.
 2. The method of claim 1, wherein irrigation fluid isapplied continuously at the flow rate or a different flow rate in thefirst flow rate range through the irrigation lumen while the distalportion of the catheter is removed from the first calyx and insertedinto the second calyx.
 3. The method of claim 1, further comprising:after inserting the distal portion into the kidney, continuouslyapplying irrigation fluid through the irrigation lumen and out from atleast one of the irrigation ports into the kidney until irrigation fluidreturns through the vacuum lumen to outside of the patient.
 4. Themethod of claim 1, further comprising: after inserting the distalportion into the first calyx, continuously applying irrigation fluidthrough the irrigation lumen and out from at least one of the irrigationports into the kidney until irrigation fluid returns through the vacuumlumen to outside of the patient.
 5. The method of claim 1, furthercomprising: after inserting the distal portion into the second calyx,continuously applying irrigation fluid through the irrigation lumen andout from at least one of the irrigation ports into the kidney untilirrigation fluid returns through the vacuum lumen to outside of thepatient.
 6. The method of claim 1, further comprising: removing thedistal portion from the second calyx and inserting the distal portioninto an additional calyx of the kidney; applying irrigation fluid at theflow rate or a different flow rate in the first flow rate range throughthe irrigation lumen and out from at least one of the irrigation ports;removing kidney stones from the additional calyx by applying suctionthrough the vacuum lumen; applying irrigation fluid at the flow rate ora different flow rate in the second flow rate range through theirrigation lumen; and steering the distal portion within the additionalcalyx by manipulating the wire pull member.
 7. The method of claim 6,wherein the first calyx, the second calyx, or the additional calyxincludes a calyx within a lower pole of the kidney.
 8. The method ofclaim 1, wherein the catheter system is configured to allow kidney stonetransport through the vacuum lumen when the distal portion is bent toform a curve in the range of about 100 degrees to about 200 degrees. 9.The method of claim 1, wherein the irrigation lumen is fixed withrespect to the vacuum lumen.
 10. The method of claim 1, wherein at leastone of the plurality of irrigation ports is configured to create anirrigation stream that extends radially outward away from a longitudinalaxis of the distal portion.
 11. The method of claim 10, wherein all ofthe plurality of irrigation ports are configured to create theirrigation stream that extends radially outward away from thelongitudinal axis of the distal portion.
 12. The method of claim 1,wherein the plurality of irrigation ports are configured to create anirrigation stream that diverges away from a longitudinal axis of thedistal portion.
 13. The method of claim 1, further comprising a nozzleincorporated into the distal portion and the nozzle forms the distalface of the distal portion.
 14. The method of claim 1, wherein thevacuum lumen has an inner diameter greater than 2 mm.
 15. The method ofclaim 1, wherein the vacuum lumen has an inner diameter of about 2.5 mm.16. The method of claim 1, wherein the catheter system further comprisesa direct visualization device configured to be movable within the vacuumlumen and inserting the distal portion into the kidney, first calyx, orsecond calyx is done while visualizing the kidney, first calyx, orsecond calyx using the direct visualization device.
 17. The method ofclaim 16, wherein the direct visualization device is configured to beremoved from within the vacuum lumen prior to kidney stone transportthrough the vacuum lumen.
 18. The method of claim 17, further comprisingremoving the direct visualization device from within the vacuum lumenprior to removing kidney stones from the first calyx and replacing thedirect visualization device into the vacuum lumen prior to inserting thedistal portion into the second calyx.
 19. The method of claim 1, whereinthe first flow rate range is from about 5 ml/min to about 20 ml/min. 20.The method of claim 1, wherein the second flow rate range is from about50 ml/min to about 200 ml/min.